PresbyopiaNCT05068479
Safety & Efficacy of the Laser Scleral Microporation Procedure
A study testing Bilateral Laser Scleral Microporation procedure in people with Presbyopia, run by ACE Vision Group, Inc. at 1 site in Panama.
Trial summary
A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment Read more about this study
- Who is it for?
- Ages 48 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Bilateral Laser Scleral Microporation procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePanama
- Study dates
- 29 Apr 2021to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to understand and sign an informed consent;
- Willing and able to adhere to the instructions set forth in this protocol;
- 48 years of age or greater, of either gender or any race;
- Less than (<) 1.00D of astigmatism in each eye, measured by manifest refraction;
- Manifest refraction spherical equivalent refraction (MRSE) of less than or equal to +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery may qualify; however, the subject must have had the Laser Vision Correction (LVC) at least 12 months prior to the LSM procedure and be stable.
- Uncorrected distance visual acuity (UDVA) is better than or equal to 20/40 (logMAR 0.30) in each eye, and a Corrected Distance Visual Acuity (CDVA) is better than or equal to 20/25 (logMAR 0.10) in each eye;
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- Demonstrate Stereopsis of 100 seconds of arc or better using a Randot stereoscopic fly test with near correction;
- In good ocular health with the exception of presbyopia;
- Presbyopia as demonstrated by:
- Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more at 40cm in each eye; and
- Reduced near visual acuity at 40cm when corrected for distance (DCNVA) of 20/50 (logMAR 0.40) or worse in each eye; and
- Minimum non-adjusted NAVQ score of 10;
- Intraocular pressure (IOP) >11mmHg and < 30 mmHg in each eye without IOP lowering medication;
- Less than or equal to (≤) 0.50D difference between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent;
- If the subject has had Laser Vision Correction (LVC) within 1-2 years prior to the LSM procedure, stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the LSM procedure. Manifest refraction spherical equivalent cannot vary more than 0.50D from current spectacles that are at least 12 months of age, or from a documented refraction at least 12 months prior to the preoperative baseline exam; if baseline data is available.
- Completed a washout period of two weeks (14 days) prior to LSM procedure from prior treatment with:
- With prior medical clearance: non steroidal anti-inflammatory drugs (NSAIDs), blood thinners, aspirin, and other substances which may increase bleeding; Anti-oxidants, which could affect blood thinning: Any antioxidant supplements (e.g., Vitamin E, Acai, Ocuvite, greater than 1000mg of Omega-3, etc); Antioxidant food supplements, such as shitake mushroom, mushroom extract and oral antioxidants
Who cannot join
- Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
- History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
- Presence of ocular pathology other than cataract such as:
- Amblyopia or strabismus Corneal abnormalities or disease History of Dry Eye treatments/devices (example: hot compresses, punctal plugs, automated or manual thermal expression, intense pulse light, nasolacrimal stimulation, thermal lid treatments, or any dry eye medications such as Cyclosporine, liftegrast, or topical steroids) Pupil abnormalities (e.g., corectopia, Adie's) Capsule or zonular abnormalities Intraocular inflammation Retinal/macular disease or pathology Glaucoma (any type)
- History of prior ocular surgery, including:
- Previous corneal surgery (e.g. penetrating keratoplasty, DSEAK/DSEK/DMEK/ lamellar keratoplasty), except for LASIK, SMILE, EpiLASIK/LASEK, or PRK; Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy); Previous retinal surgery (e.g. retinal break, repair related to ocular trauma or detachment, or pathology that is likely to require surgical intervention such as lattice degeneration
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- Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 (logMAR 0.18) or worse (e.g., macular degeneration);
- Keratoconus or keratoconus suspect with CDVA of less than (<) 20/20 (logMAR > 0.00) at distance;
- Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
- Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
- Acute or chronic disease or illness that could increase the operative risk or confound the study outcome(s) (e.g., diabetes mellitus, immunocompromised, connective tissue disease);
- Uncontrolled systemic or ocular disease;
- Any abnormality preventing reliable applanation tonometry in EITHER eye;
- Undilatable pupil such that one cannot examine the periphery of the retina;
- Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.
- History of scleral ectasia, scleritis, or episcleritis; or thin sclera < 400 microns, as determined by taking the average of three measurements with ultrasound biomicroscopy (UBM) pachymetry or optical coherence tomography (OCT);
- History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA or (where measured at select sites) OSI > 2.5;
- Known allergies tp study medications including topical steroids, antibiotics and NSAIDs;
- Per Principal Investigator (PI) discretion, as described below:
- Note: This above list of exclusion criteria is not all inclusive. Investigators should use medical judgement to exclude patients that have diseases/conditions which may compromise study results and/or patients that are not ideal candidates. Patient affect and/or expectations may be included in the evaluation of candidacy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety & Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation
A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment
Read the detailed description
This is a prospective, controlled, single-center clinical study to evaluate the safety and efficacy of the Laser Scleral Microporation Procedure.
Laser Scleral Microporation Procedure is a treatment to restore visual and accommodative function in presbyopic patients. The subjects are bilaterally treated with the Laser Scleral Microporation procedure.
- Conditions
- Presbyopia
- Being tested
- Bilateral Laser Scleral Microporation procedure
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Laser Scleral Microporation procedureDevice
Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.
| Study group | Role | What they receive |
|---|---|---|
| Natural Emmetropic Presbyopes | Experimental | Patients that did not undergo any vision correcting surgery or implantation of an intraocular lens but suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure. Receives: Device: Bilateral Laser Scleral Microporation procedure |
| Post Laser Vision Correction (LVC) Emmetropic Presbyopes | Experimental | Patients that underwent laser vision correction procedure (e.g. LASIK) in the past and suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure. Receives: Device: Bilateral Laser Scleral Microporation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
Binocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is done binocularly under photopic light conditions.
Measured: 12 months postoperative
Secondary outcomes (34)
Monocular Uncorrected Distance Visual Acuity (UDVA) @4m
Monocular UDVA is measured with ETDRS charts placed in 4m distance. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Uncorrected Distance Visual Acuity (UDVA) @4m
Binocular UNVA is measured with ETDRS charts placed in 4m distance. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm
Monocular UIVA is measured with ETDRS charts placed in 60cm distance. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm
Binocular UIVA is measured with ETDRS charts placed in 60cm distance. This assessment is done binocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Uncorrected Near Visual Acuity (UNVA) @40cm
Monocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
Binocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is done binocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Manifest refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Best Corrected Distance Visual Acuity (CDVA) @4m
Monocular CDVA is measured with ETDRS charts placed in 4m distance using best aided corrective glasses. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Best Corrected Distance Visual Acuity (CDVA) @4m
Binocular CDVA is measured with ETDRS charts placed in 4m distance using best aided corrective glasses. This assessment is done binocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm
Monocular DCIVA is measured with ETDRS charts placed in 60cm distance using corrective glasses for far distance. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm
Binocular DCIVA is measured with ETDRS charts placed in 60cm distance using corrective glasses for far distance. This assessment is done binocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Distance Corrected Near Visual Acuity (DCNVA) @40cm
Monocular DCNVA is measured with ETDRS charts placed in 40cm distance using corrective glasses for far distance. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Distance Corrected Intermediate Near Acuity (DCNVA) @40cm
Binocular DCNVA is measured with ETDRS charts placed in 40cm distance using corrective glasses for far distance. This assessment is done binocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Determination of reading prescription
Reading prescription is determined by using refraction for fars distance, placing ETDRS charts in 40cm distance and adding positive lenses to the refraction glasses until further addition of positive lenses has no more effect on the reading ability of the subject. The added positive lenses (in diopter) is noted down in the CRF.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Best Corrected Near Visual Acuity (CNVA) @40cm
Monocular CNVA is measured with ETDRS charts placed in 40cm distance using corrective glasses for near distance (reading prescription). This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Accommodative Amplitude using binocular minus lens to blur
The amplitude of accommodation will be assessed binocularly at distance with an introduction of minus power over the distance prescription to stimulate accommodation. Instruct the patient to focus on the distance vision chart, and slowly add minus power in -0.25D steps until the subject reports first sustained blur on the line. Record the dioptric value where the subject reports the first sustained blur. Subtract the distance prescription from this value to obtain the accommodative amplitude using this method. This test is repeated three times. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Accommodative Amplitude using monocular minus lens to blur
The amplitude of accommodation will be assessed monocularly at distance with introduction of minus power over the distance prescription to stimulate accommodation. Place an occluder lens into the trial frame over the left eye. Instruct the patient to focus on the distance vision chart and slowly add minus power in -0.25D steps until the subject reports first sustained blur on the line. Record the dioptric value where the subject reports the first sustained blur. Subtract the distance prescription from this value to obtain the accommodative amplitude using this method. This test is repeated three times. This assessment is done monocularly under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
iReST reading test
The reading speed will be measured using the International Reading Speed Texts (iReST™), a standardized assessment of reading speed. For this test, the reading prescription determined at each visit will be used and the assessment will be done under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Accommodation testing
The iTrace (Tracey Technologies, Houston, TX or equivalent) wavefront aberrometer is used for the accommodation testing. The iTrace measures aberrometry at distance using the distance prescription in a trial frame, as well as at 60cm and 40cm using a near rod.
Objective measures will be performed to assess the change in accommodation based upon the location of the visual target.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Wavefront measurement
The iTrace (Tracey Technologies, Houston, TX or equivalent) measures aberrometry at distance, 60cm and 40cm. Measurements will be performed unaided and aided using the distance prescription based upon the manifest refraction. Coma, Spherical Aberration, and Trefoil exams will also be recorded at distance, 60cm and 40cm.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Auto-Keratometry
Simulated-keratometry (SimK) will be measured using the iTrace unit (Tracey Technologies, Houston, TX).
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Corneal topography
Anterior surface corneal topography using placido disc will be measured using the iTrace unit (Tracey Technologies, Houston, TX).
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Corneal tomography
Corneal tomography using Scheimpflug imaging will be measured using the Pentacam HR (Oculus, Wetzlar, Germany).
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative
Stereoacuity
Stereoacuity will be measured under photopic conditions using a standard randot stereoscopic test at 40cm with the subject's reading prescription.
For this test, the reading prescription determined at each visit will be used and the assessment will be done under photopic light conditions.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Pupillometry under mesopic lighting conditions
Measurement of pupil size will be performed under mesopic lighting conditions. The Neuroptics VIP® -200 pupillometer is being used for this assessment
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Pupillometry under photopic lighting conditions
Measurement of pupil size will be performed under photopic lighting conditions. The Neuroptics VIP® -200 pupillometer is being used for this assessment
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular contrast acuity
Contrast acuity will be measured using ETDRS optotypes with 10% contrast placed in 4m distance. For this test, best distance aided corrective glasses are used and this assessment is done monocularly under photopic light conditions.
Measured: 1 month postoperative; 12 months postoperative; 24 months postoperative
Binocular contrast acuity
Contrast acuity will be measured using ETDRS optotypes with 10% contrast placed in 4m distance. For this test, best distance aided corrective glasses are used and this assessment is done binocularly under photopic light conditions.
Measured: 1 month postoperative; 12 months postoperative; 24 months postoperative
Axial length measurement
The axial length of the eye will be measured using a partial coherence interferometry device (IOLMaster version 7.5, Carl Zeiss Meditec).
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative
Intraocular pressure measurement
Intraocular Pressure will be measured using Goldmann applanation tonometry. Three measurements will be performed per eye at each visit.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Cycloplegic refraction
A cycloplegic refraction at distance using 1% tropicamide will be performed. Following values will be recorded: sphere, cylinder, axis of cylinder.
Measured: 12 months postoperative; 24 months postoperative
Ultrasound biomicroscopy
Ultrasonic Biomicroscopy (UBM) or OCT will be performed to assess scleral thickness and anatomical changes with accommodation. Three nonimmersion thickness measurements will be taken 4mm from the limbus (in any quadrant) to ensure the tissue thickness is sufficient for success and safety of the procedure.
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative
Slitlamp examination
The slitlamp examination is one examination to analyse the integrity of the eye structures.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
Corneal clarity anterior chamber cells anterior chamber flare lens grading using the LOCS III card Conjunctival/scleral vessel injection Degree of choroidal hue Conjunctival edema Conjunctival hemorrhages Eyelid edema
Measured: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Dilated fundus exam
A Dilated Fundus Exam will also be performed to examine the vitreous, optic nerve, blood vessels, macula and retina to identify eye related diseases or anatomical anomalies.
Measured: 12 months postoperative; 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start29 Apr 2021
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Why it stopped: Study terminated early to pursue Gen II laser advancements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACE Vision Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Jackson, MD, Study director, Ace Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068479
- Sponsor's protocol ID
- PAN-AVG-PRES-2020-01
- Status last verified
- Aug 2023
- First submitted
- 28 Sep 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety & Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation
- ClinicalTrials.gov ID
- NCT05068479
- Acronym / sponsor ID
- PAN-AVG-PRES-2020-01
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early to pursue Gen II laser advancements
- Enrolment
- 38 participants (actual)
- Lead sponsor
- ACE Vision Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment
Detailed description
This is a prospective, controlled, single-center clinical study to evaluate the safety and efficacy of the Laser Scleral Microporation Procedure.
Laser Scleral Microporation Procedure is a treatment to restore visual and accommodative function in presbyopic patients. The subjects are bilaterally treated with the Laser Scleral Microporation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Natural Emmetropic Presbyopes | Experimental | Device: Bilateral Laser Scleral Microporation procedurePatients that did not undergo any vision correcting surgery or implantation of an intraocular lens but suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure. |
| Post Laser Vision Correction (LVC) Emmetropic Presbyopes | Experimental | Device: Bilateral Laser Scleral Microporation procedurePatients that underwent laser vision correction procedure (e.g. LASIK) in the past and suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure. |
Who may qualify
- Ages
- 48 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Willing and able to understand and sign an informed consent;
- Willing and able to adhere to the instructions set forth in this protocol;
- 48 years of age or greater, of either gender or any race;
- Less than (<) 1.00D of astigmatism in each eye, measured by manifest refraction;
- Manifest refraction spherical equivalent refraction (MRSE) of less than or equal to +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery may qualify; however, the subject must have had the Laser Vision Correction (LVC) at least 12 months prior to the LSM procedure and be stable.
Key exclusion criteria (20 listed)
- Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
- History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
- Presence of ocular pathology other than cataract such as:
- Amblyopia or strabismus Corneal abnormalities or disease History of Dry Eye treatments/devices (example: hot compresses, punctal plugs, automated or manual thermal expression, intense pulse light, nasolacrimal stimulation, thermal lid treatments, or any dry eye medications such as Cyclosporine, liftegrast, or topical steroids) Pupil abnormalities (e.g., corectopia, Adie's) Capsule or zonular abnormalities Intraocular inflammation Retinal/macular disease or pathology Glaucoma (any type)
- History of prior ocular surgery, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Laser Scleral Microporation procedurePartial depth scleral microporations with an Er:YAG laser in a predetermined pattern. | Device | Natural Emmetropic Presbyopes, Post Laser Vision Correction (LVC) Emmetropic Presbyopes |
Primary outcome
Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
Time frame: 12 months postoperative
Binocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is done binocularly under photopic light conditions.
34 secondary outcomes
Monocular Uncorrected Distance Visual Acuity (UDVA) @4m
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Uncorrected Distance Visual Acuity (UDVA) @4m
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Uncorrected Near Visual Acuity (UNVA) @40cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Manifest refraction
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Best Corrected Distance Visual Acuity (CDVA) @4m
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Best Corrected Distance Visual Acuity (CDVA) @4m
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Distance Corrected Near Visual Acuity (DCNVA) @40cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Binocular Distance Corrected Intermediate Near Acuity (DCNVA) @40cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Determination of reading prescription
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular Best Corrected Near Visual Acuity (CNVA) @40cm
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Accommodative Amplitude using binocular minus lens to blur
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Accommodative Amplitude using monocular minus lens to blur
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
iReST reading test
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Accommodation testing
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Wavefront measurement
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Auto-Keratometry
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Corneal topography
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Corneal tomography
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative
Stereoacuity
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Pupillometry under mesopic lighting conditions
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Pupillometry under photopic lighting conditions
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Monocular contrast acuity
Time frame: 1 month postoperative; 12 months postoperative; 24 months postoperative
Binocular contrast acuity
Time frame: 1 month postoperative; 12 months postoperative; 24 months postoperative
Axial length measurement
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative
Intraocular pressure measurement
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Cycloplegic refraction
Time frame: 12 months postoperative; 24 months postoperative
Ultrasound biomicroscopy
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative
Slitlamp examination
Time frame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
Dilated fundus exam
Time frame: 12 months postoperative; 24 months postoperative
Results and safety
The study was stopped early (reason given: Study terminated early to pursue Gen II laser advancements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Jackson, MD study director
Ace Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Laser Scleral Microporation procedure in people with Presbyopia, run by ACE Vision Group, Inc. at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated early to pursue Gen II laser advancements). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular Uncorrected Near Visual Acuity (UNVA) @40cm (time frame: 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.