Refractive Error - Myopia SevereNCT03021707
Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
A study testing WaveLight® Ultraviolet Femtosecond (FS) Laser System and Laser Assisted Lenticular Extraction in people with Refractive Error - Myopia Severe and Refractive Error - Myopia Simple, run by Alcon Research at 4 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Refractive Error - Myopia Severe, Refractive Error - Myopia Simple
- What is being tested?
- WaveLight® Ultraviolet Femtosecond (FS) Laser System and Laser Assisted Lenticular Extraction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Mar 2017to 17 Oct 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;
- Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;
- Able to comprehend and provide documented informed consent;
- Willing and able to comply with schedule for follow-up visits;
- Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;
- Presence of natural lens in study eye;
- A treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Pregnant or nursing;
- Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;
- Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;
- Current use of medications with known ocular side effects;
- Predicted residual stromal bed thickness <300 micrometers (μm) in study eye
- Ocular conditions in the study eye;
Show all 13Show fewer
- Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone;
- Residual, recurrent or active ocular disease that may impact study outcomes;
- Previous or current diagnosis of dry eye;
- Known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care;
- Pre-existing corneal opacities in study eye;
- Contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Alcon Investigative Site
Houston, Texas, 77027
Alcon Investigative Site
Sioux Falls, South Dakota, 57108
About this study
The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.
- Being tested
- WaveLight® Ultraviolet Femtosecond (FS) Laser System, Laser Assisted Lenticular Extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveLight® Ultraviolet Femtosecond (FS) Laser SystemDevice
Also called Model 1026, UV-FS laser
Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction
Laser Assisted Lenticular ExtractionProcedure or surgery
Also called UV-Femto
Used for refractive error correction
| Study group | Role | What they receive |
|---|---|---|
| UV-FS laser | Experimental | WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant) Receives: Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System; Procedure: Laser Assisted Lenticular Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of optical treatment zone corneal haze
Corneal haze will be assessed on a scale of 0 to 4, where 0 = clear or no haze can be seen, and 4 = opacity is visible without slit lamp, greatly obscures iris detail.
Measured: Up to Month 6 (post-operative)
Mean change from screening in presence of disruption in the integrity of retinal layers in the macula
Retinal layer integrity will be assessed by a posterior segment ocular coherence tomography (OCT) scan of the study eye. Any disruption (change) in the retinal layers in the macula as compared to the screening scan will assess retinal integrity.
Measured: Screening, Up to Month 6 (post-operative)
Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure
Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.
Measured: Screening, Up to Month 6 (post-operative)
Mean percentage change in lens opacification from screening to each visit post procedure
A Scheimpflug scan will be performed to evaluate any opacification of the crystalline lens in the study eye and a Pentacam Nucleus Staging (PNS) grade from 0 to 5 will be assigned.
Measured: Screening, Up to Month 6 (post-operative)
Mean percentage change in foveal thickness from screening to each visit post procedure
Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.
Measured: Screening, Up to Month 6 (post-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start7 Mar 2017
- Primary completion27 May 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive Error - Myopia SevereStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021707
- Sponsor's protocol ID
- RFO268-E001
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2017
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
- ClinicalTrials.gov ID
- NCT03021707
- Acronym / sponsor ID
- RFO268-E001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 16 Jan 2017 (estimated)
- 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.
The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UV-FS laser | Experimental | Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System, Procedure: Laser Assisted Lenticular ExtractionWaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;
- Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;
- Able to comprehend and provide documented informed consent;
- Willing and able to comply with schedule for follow-up visits;
- Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;
Key exclusion criteria (13 listed)
- Pregnant or nursing;
- Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;
- Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;
- Current use of medications with known ocular side effects;
- Predicted residual stromal bed thickness <300 micrometers (μm) in study eye
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 |
|---|---|---|
| WaveLight® Ultraviolet Femtosecond (FS) Laser SystemAlso: Model 1026, UV-FS laserUtilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction | Device | UV-FS laser |
| Laser Assisted Lenticular ExtractionAlso: UV-FemtoUsed for refractive error correction | Procedure or surgery | UV-FS laser |
Primary outcome
Presence of optical treatment zone corneal haze
Time frame: Up to Month 6 (post-operative)
Corneal haze will be assessed on a scale of 0 to 4, where 0 = clear or no haze can be seen, and 4 = opacity is visible without slit lamp, greatly obscures iris detail.
Mean change from screening in presence of disruption in the integrity of retinal layers in the macula
Time frame: Screening, Up to Month 6 (post-operative)
Retinal layer integrity will be assessed by a posterior segment ocular coherence tomography (OCT) scan of the study eye. Any disruption (change) in the retinal layers in the macula as compared to the screening scan will assess retinal integrity.
Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure
Time frame: Screening, Up to Month 6 (post-operative)
Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.
Mean percentage change in lens opacification from screening to each visit post procedure
Time frame: Screening, Up to Month 6 (post-operative)
A Scheimpflug scan will be performed to evaluate any opacification of the crystalline lens in the study eye and a Pentacam Nucleus Staging (PNS) grade from 0 to 5 will be assigned.
Mean percentage change in foveal thickness from screening to each visit post procedure
Time frame: Screening, Up to Month 6 (post-operative)
Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.
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 7 Apr 2022.
- 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.
Clinical Manager, Surgical study director
Alcon Research
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WaveLight® Ultraviolet Femtosecond (FS) Laser System and Laser Assisted Lenticular Extraction in people with Refractive Error - Myopia Severe and Refractive Error - Myopia Simple, run by Alcon Research at 4 sites in 3 countries.
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 8 inclusion and 13 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Ireland, Singapore. 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?
Presence of optical treatment zone corneal haze (time frame: Up to Month 6 (post-operative)). The study lists 5 primary outcomes in all. 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 7 Apr 2022.