PresbyopiaNCT04151550
Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines)
A study testing Bilateral Laser Scleral Microporation procedure in people with Presbyopia, run by ACE Vision Group, Inc. at 1 site in Philippines.
Trial summary
A 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
- 50 participants
- Where
- 1 sitePhilippines
- Study dates
- 25 Sep 2019to 28 Feb 2025
- 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 attend postoperative examinations per protocol schedule;
- 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;
- Mean Refractive Spherical Equivalent (MRSE) of less than or equal to 0.50D for distance vision;
- 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 Stereo 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;
- 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 (MRSE) 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, aspiring and other substances which may increase bleeding; b) Anti-oxidants, which could affect blood thinning: (i) Any antioxidant supplements (e.g., Vitamin E, Acai, Ocuvite, greater than 1000mg of Omega-3, etc.); (ii) 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
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- 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, EpiLASEK, or PRK;
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) with the exception of uncomplicated phacoemulsification with intraocular lens implantation;
- Previous retinal surgery (e.g, retinal break, repair related to ocular trama or detachment, or pathology that is likely to require surgical intervention such as lattice degeneration.
- 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 15 prism diopters (PD) horizontally and/or over 2 PD 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 ocular coherence tomography;
- History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA or OSI > 2.5;
- Known allergies to study medications including topical steroids, antibiotics and NSAIDs;
- Per Principal Investigator (PI) discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation
A 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
- Keywords
- Presbyopia, Sclera, Laser Scleral Microporation
- 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
Device: Laser Scleral Microporation
Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.
| Study group | Role | What they receive |
|---|---|---|
| AVG LSM Procedure | Other | Ace Vision Group LSM procedure performed on both eyes. 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 Distance Corrected Near Visual Acuity (DCNVA) @40cm
Binocular DCNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed under photopic lighting conditions.
Measured: 12 months postoperative
Secondary outcomes (19)
Autorefraction
An autorefractor or automated refractor is a computer-controlled machine used during an eye examination to provide an objective measurement of a subject's refractive error.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) @4m
UDVA is measured with ETDRS charts placed at 4m distance. This assessment is performed monocularly under photopic lighting conditions.
Measured: 1 day; 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Binocular Uncorrected Distance Visual Acuity (UDVA) @4m
UNVA is measured with ETDRS charts placed at 4m distance. This assessment is performed binocularly under photopic lighting conditions.
Measured: 1 week; 1 month ; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm
UIVA is measured with ETDRS charts placed at 60cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Measured: 1 week 1 month; 3 months 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
UNVA is measured with ETDRS charts placed at 40cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Manifest Refraction
This is the manual way to determine the best lenses, by placing various lenses in front of the subject's eyes and asking questions. The manifested refraction is measured by means of a phoropter and ETDRS charts at 4m. The data contains values for sphere, cylinder and axis of cylinder. This data will also be used to calculate the Manifest Refractive Spherical Equivalent (MRSE). This assessment is performed under photopic lighting conditions
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Best Corrected Distance Visual Acuity (CDVA) @4m
CDVA is measured with ETDRS charts placed at 4m distance using best aided corrective glasses. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm
DCIVA is measured with ETDRS charts placed at 60cm distance using corrective glasses for far distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 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 performed monocularly under photopic lighting conditions.
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 (DCNVA) @40cm
Monocular CNVA is measured with ETDRS charts placed in 40cm distance using corrective glasses for near distance (reading prescription). This assessment is performed monocularly under photopic lighting 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 & monocular minus lens to blur
The amplitude of accommodation is the maximum potential increase in optical power that an eye can achieve in adjusting its focus. The amplitude of accommodation will be assessed binocularly first at distance with an introduction of minus power over the distance prescription to stimulate accommodation. Instruct the subject to focus on 20/20 line of the ETDRS charts at 4m, 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 repeat three times). This assessment is performed binocularly first, then monocularly under photopic lighting conditions.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
IReST
The International Reading Speed Texts (IReST) consists of paragraphs of text (approx. 130 words per text) which is a standardized assessment of reading speed. The reading speed will be measured using the IReST using the subject's reading prescription determined at each visit. This assessment will be performed under photopic lighting conditions.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Stereoacuity
Stereopsis, or depth perception, is based on the horizontal retinal image disparity between the two eyes. Stereoacuity, which is a threshold measure of the acuteness of this depth perception, provides an indication of the level of sensory binocularity an subject has. Stereoacuity will be measured using a the Precision Vision Stereo Fly 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 performed under photopic lighting conditions.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Contrast Sensitivity
Contrast sensitivity is the subject's ability to distinguish the foreground from the background.
This will be measured using ETDRS (Sloan Revised Low Contrast Chart 2425) optotypes with 10% contrast while wearing distance correct placed in 4m distance. For this assessment will be performed under photopic lighting conditions.
Measured: 1 month postoperative; 12 months postoperative; 24 months postoperative
Wavefront Aberrometry
The iTrace (Tracey Technologies, Houston, TX) measures aberrometry at distance 60cm and 40cm. Measurements will be performed uncorrected and corrected using the distance correction in loose lenses held in the Tracey trial frames. Higher order on lower order aberrations will be recorded using distance correction at distance, 60cm and 40cm.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Effective Range of Focus
The iTrace (version 5.3.1 or higher, Tracey Technologies, Houston, TX) wavefront aberrometer is used for the DOF 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 EROF based upon the location of the visual target.
Measured: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
Optical Scatter
The HD Analyzer determines the Objective Scattering Index (OSI) which determines how a point source of light is imaged on the retina (recommended version 2400 -Keeler, Malver, PA).
Measured: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
Intraocular Pressure
Intraocular Pressure will be measured using Goldmann applanation tonometry. Tow measurements will be performed per eye at each visit. If there is more than 2mmHg between the two readings, a third reading will be performed. The value will be an average.
Measured: 1, Day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
UBM Accommodation
An ultrasound eye exam that makes a more detailed image. The VuMAX HD (Sonomed Escalon, NY) is the recommended device for evaluation .
Measured: 1 month; 12 month & 24 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start25 Sep 2019
- Primary completion18 Dec 2024
- Study completion28 Feb 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT04151550
- Sponsor's protocol ID
- AVG-PHIL-2019-02
- Status last verified
- Feb 2025
- First submitted
- 1 Nov 2019
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation
- ClinicalTrials.gov ID
- NCT04151550
- Acronym / sponsor ID
- AVG-PHIL-2019-02
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Sclera, Laser Scleral Microporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ACE Vision Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 5 Nov 2019 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVG LSM Procedure | Other | Device: Bilateral Laser Scleral Microporation procedureAce Vision Group LSM procedure performed on both eyes. |
Who may qualify
- Ages
- 48 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to understand and sign an informed consent;
- Willing and able to attend postoperative examinations per protocol schedule;
- 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;
- Mean Refractive Spherical Equivalent (MRSE) of less than or equal to 0.50D for distance vision;
Key exclusion criteria (28 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:
- History of prior ocular surgery, including:
- 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);
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 procedureDevice: Laser Scleral Microporation Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern. | Device | AVG LSM Procedure |
Primary outcome
Binocular Distance Corrected Near Visual Acuity (DCNVA) @40cm
Time frame: 12 months postoperative
Binocular DCNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed under photopic lighting conditions.
19 secondary outcomes
Autorefraction
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) @4m
Time frame: 1 day; 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Binocular Uncorrected Distance Visual Acuity (UDVA) @4m
Time frame: 1 week; 1 month ; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm
Time frame: 1 week 1 month; 3 months 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Manifest Refraction
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Best Corrected Distance Visual Acuity (CDVA) @4m
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Monocular & Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 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
Monocular Best 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
Accommodative Amplitude using binocular & monocular minus lens to blur
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
IReST
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Stereoacuity
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Contrast Sensitivity
Time frame: 1 month postoperative; 12 months postoperative; 24 months postoperative
Wavefront Aberrometry
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Effective Range of Focus
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
Optical Scatter
Time frame: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
Intraocular Pressure
Time frame: 1, Day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
UBM Accommodation
Time frame: 1 month; 12 month & 24 month postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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 Philippines.
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 16 inclusion and 28 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 Philippines. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Distance Corrected Near Visual Acuity (DCNVA) @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 10 Mar 2025.