Epithelial Basement Membrane DystrophyNCT06618508
Manual Debridement vs Phototherapeutic Keratectomy in the Treatment of Corneal Basement Membrane Dystrophy
A study testing Manual debridement and Phototherapeutic keratectomy in people with Epithelial Basement Membrane Dystrophy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Of the few comparisons made in the existing literature, the results of PTK are comparable to those documented for manual debridement (MD). However, the shorter length of follow-up in patients with MD may have underestimated the associated complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Basement Membrane Dystrophy
- What is being tested?
- Manual debridement and Phototherapeutic keratectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age;
- Ability to give free and informed consent
- At least 1-year follow-up possible
- Patients with bilateral basal membrane corneal dystrophy who are symptomatic (recurrent corneal erosions, visual disturbances) and are candidates for bilateral surgery.
Who cannot join
- Patient under 18 years of age;
- History of ocular infection with herpes simplex virus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Catherine Tessier, M.Sc. contact
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Comparison of Efficacy and Safety Between Manual Debridement and Phototherapeutic Keratectomy (PTK) in the Treatment of Corneal Basement Membrane Dystrophy
Of the few comparisons made in the existing literature, the results of PTK are comparable to those documented for manual debridement (MD). However, the shorter length of follow-up in patients with MD may have underestimated the associated complications. Our study, therefore, aims to offer a comparison between these two techniques to clarify the choice of effective treatment with a good safety profile.
Read the detailed description
Epithelial Basement Membrane Dystrophy (EBMD) affects the anterior cornea, impacting about 2% of the population. EBMD is characterized by alterations and duplications of the basement membrane, a tissue layer that connects the epithelium to the underlying eye tissue. Dysfunction of the basement membrane prevents proper adhesion of the overlying epithelium, leading to recurrent corneal erosions. Additionally, tissue protrusions infiltrate the epithelium, creating surface irregularities that cause symptoms like blurred vision and irregular corneal topographies. This abnormal proliferation results in microcysts and corneal irregularities resembling fingerprints and maps. These surface irregularities can be observed in optical coherence tomography (OCT) images showing epithelial thickening. Non-invasive medical treatments are the first line of therapy, including lubricating drops and hypertonic solutions to protect the ocular surface and promote epithelial adhesion. For corneal erosions, soft contact lenses are used to aid healing. Surgical interventions such as manual debridement and phototherapeutic keratectomy (PTK) are required in refractory cases. These are also indicated for patients preparing for cataract surgery to optimize preoperative corneal measurements and postoperative optical outcomes. Manual debridement (MD), a technique since 1952, involves scraping off the irregular epithelium to allow a new layer to form. Some surgeons use 20% ethanol on the cornea before scraping with a blade or sponge, preserving the basement membrane. This method is simple, cost-effective, and has an 85% success rate in treating recurrent corneal erosions. However, recurrence rates are up to 24%, with the first recurrence typically within six months. Corneal opacities can form between 7 and 41 days post-procedure. Over the past two decades, PTK has become increasingly used for anterior corneal pathologies, including EBMD. PTK uses a 193nm excimer laser to break molecular bonds between cells on the epithelial surface. It is considered a more reliable, safe, and precise alternative to manual debridement, completely obliterating the basement membrane and potentially reducing recurrence rates. Success rates without recurrence range from 46% to 100%, with minimal complications. Unlike manual debridement, PTK may induce a hyperopic shift, which stabilizes within a year. Corneal erosions and pain recur at about 13% over an average of 9.7 months. Comparative studies between these two methods are scarce, and more data is needed to favor one technique over the other. Limited comparisons suggest PTK results are comparable to manual debridement, though shorter follow-ups in MD patients may underestimate associated complications. Our study aims to compare these techniques to describe the efficacy and safety of both treatments.
- Conditions
- Epithelial Basement Membrane Dystrophy
- Being tested
- Manual debridement, Phototherapeutic keratectomy
- Medical subject headings
- Corneal dystrophy, epithelial basement membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual debridementProcedure or surgery
Traditional technique which consists of scraping off the irregular epithelium to allow a new layer to form.
Phototherapeutic keratectomyProcedure or surgery
New technique which has been increasingly used and which consists of a 193nm excimer laser that breaks molecular bonds between cells on the epithelial surface.
| Study group | Role | What they receive |
|---|---|---|
| Manual debridement | Active comparator | Manual debridement is a technique that has existed since 1952 and whose objective is to remove the irregular epithelium by scraping with an instrument, thus allowing the formation of a new superficial layer. Some surgeons use 20% ethanol which they apply to the cornea to debride it before using a blade or sponge to complete the procedure. In this technique, the basement membrane is preserved. This method is still used being simple and cost effective. Its effectiveness in the treatment of recurrent corneal erosions is demonstrated by a success rate estimated at 85%. Thus, it is one of the methods of treating epithelial basement membrane dystrophy. However, the recurrence rate associated with manual debridement is up to 24%, and the average duration before a first recurrence is estimated at 6 months. The formation of corneal opacities was recorded between 7 and 41 days following the intervention. Receives: Procedure: Manual debridement |
| Phototherapeutic keratectomy | Experimental | Over the past two decades, phototherapeutic keratectomy (PTK) has become an increasingly used approach for the treatment of several anterior corneal pathologies, including epithelial basement membrane dystrophy. This technique consists of directing a 193nm excimer laser towards the epithelial surface in order to break the molecular bonds between cells. PTK appears to be a more reliable, safe and precise alternative to manual debridement. Unlike manual debridement, PTK completely obliterates the basement membrane which would promote a reduction in the recurrence rate according to some experts. Thus, the success rate without recurrence has been estimated between 46 to 100% by certain studies and the associated complications are minimal. Receives: Procedure: Phototherapeutic keratectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of corneal basement membrane dystrophy
Evaluated with slit-lamp morphological findings (maps, "fingerprint" lines, epithelial microcysts), imaging results including OCT (thickened basement membrane and epithelial irregularities) and patient symptoms (redness, pain, photophobia, associated with erosions).
Measured: Day 1, week 1 and months 1, 3, 6, 12 and 24 months
Secondary outcomes (5)
Corneal haze formation assessed by a corneal haze gradation scale
0: Clear with no opacity seen by any method of microscopic slit-lamp examination.
0.5: Trace or faint haze seen only by indirect, broad tangential illumination.
- Haze of minimal density seen with difficulty with direct or diffuse examination.
- Mild haze easily visible with direct focal slit lamp illumination.
- Moderate opacity that partially obscured details of iris.
- Severe opacity that completely obscured the details of intraocular structures.
Measured: 1, 3, 6, 12 and 24 months
Contrast sensitivity with the CSV-1000 Contrast Sensitivity chart with glare
Standardized contrast sensitivity test.
Measured: 1,3,6,12 and 24 months
Patient comfort using the Wong-Baker FACES pain scale
0 = no hurt; 2= hurts a little bit; 4=hurts little more; 6=hurts even more; 8=hurts whole lot; 10=hurts worst
Measured: Day 1, week 1, month 1, month 3, month 6 and month 12
Post-operative complications
Post-operative complications include persistent epithelial deficits, formation of subepithelial corneal opacities, infectious keratitis, reactivation of herpes simplex virus, scarring, and corneal infiltrates.
Measured: Day 1, week 1, month 1, month 3, month 6 and month 12
Best corrected distance visual acuity (BCVA)
This is the visual acuity measured using an eye chart. To achieve best possible visual acuity, corrective lenses are used.
Measured: 1,3,6,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Epithelial Basement Membrane DystrophyStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Jabbour, MD,CM,FRCSC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618508
- Sponsor's protocol ID
- 2025-12106
- Other IDs
- 2025
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee WS, Lam CK, Manche EE. Phototherapeutic keratectomy for epithelial basement membrane dystrophy. Clin Ophthalmol. 2016 Dec 16;11:15-22. doi: 10.2147/OPTH.S122870. eCollection 2017.
PubMed 28031698Pogorelov P, Langenbucher A, Kruse F, Seitz B. Long-term results of phototherapeutic keratectomy for corneal map-dot-fingerprint dystrophy (Cogan-Guerry). Cornea. 2006 Aug;25(7):774-7. doi: 10.1097/01.ico.0000214801.02195.d4.
PubMed 17068452Gaster RN, Ben Margines J, Gaster DN, Li X, Rabinowitz YS. Comparison of the Effect of Epithelial Removal by Transepithelial Phototherapeutic Keratectomy or Manual Debridement on Cross-linking Procedures for Progressive Keratoconus. J Refract Surg. 2016 Oct 1;32(10):699-704. doi: 10.3928/1081597X-20160712-01.
PubMed 27722758Deshmukh R, Reddy JC, Rapuano CJ, Vaddavalli PK. Phototherapeutic keratectomy: Indications, methods and decision making. Indian J Ophthalmol. 2020 Dec;68(12):2856-2866. doi: 10.4103/ijo.IJO_1524_20.
PubMed 33229661Yeu E, Hashem O, Sheha H. Treatment of Epithelial Basement Membrane Dystrophy to Optimize the Ocular Surface Prior to Cataract Surgery. Clin Ophthalmol. 2022 Mar 15;16:785-795. doi: 10.2147/OPTH.S356421. eCollection 2022.
PubMed 35321046Buffault J, Zeboulon P, Liang H, Chiche A, Luzu J, Robin M, Rabut G, Labetoulle M, Labbe A, Baudouin C. Assessment of corneal epithelial thickness mapping in epithelial basement membrane dystrophy. PLoS One. 2020 Nov 25;15(11):e0239124. doi: 10.1371/journal.pone.0239124. eCollection 2020.
PubMed 33237913
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety Between Manual Debridement and Phototherapeutic Keratectomy (PTK) in the Treatment of Corneal Basement Membrane Dystrophy
- ClinicalTrials.gov ID
- NCT06618508
- Acronym / sponsor ID
- 2025-12106
- Conditions
- Epithelial Basement Membrane Dystrophy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
Of the few comparisons made in the existing literature, the results of PTK are comparable to those documented for manual debridement (MD). However, the shorter length of follow-up in patients with MD may have underestimated the associated complications. Our study, therefore, aims to offer a comparison between these two techniques to clarify the choice of effective treatment with a good safety profile.
Detailed description
Epithelial Basement Membrane Dystrophy (EBMD) affects the anterior cornea, impacting about 2% of the population. EBMD is characterized by alterations and duplications of the basement membrane, a tissue layer that connects the epithelium to the underlying eye tissue. Dysfunction of the basement membrane prevents proper adhesion of the overlying epithelium, leading to recurrent corneal erosions. Additionally, tissue protrusions infiltrate the epithelium, creating surface irregularities that cause symptoms like blurred vision and irregular corneal topographies. This abnormal proliferation results in microcysts and corneal irregularities resembling fingerprints and maps. These surface irregularities can be observed in optical coherence tomography (OCT) images showing epithelial thickening. Non-invasive medical treatments are the first line of therapy, including lubricating drops and hypertonic solutions to protect the ocular surface and promote epithelial adhesion. For corneal erosions, soft contact lenses are used to aid healing. Surgical interventions such as manual debridement and phototherapeutic keratectomy (PTK) are required in refractory cases. These are also indicated for patients preparing for cataract surgery to optimize preoperative corneal measurements and postoperative optical outcomes. Manual debridement (MD), a technique since 1952, involves scraping off the irregular epithelium to allow a new layer to form. Some surgeons use 20% ethanol on the cornea before scraping with a blade or sponge, preserving the basement membrane. This method is simple, cost-effective, and has an 85% success rate in treating recurrent corneal erosions. However, recurrence rates are up to 24%, with the first recurrence typically within six months. Corneal opacities can form between 7 and 41 days post-procedure. Over the past two decades, PTK has become increasingly used for anterior corneal pathologies, including EBMD. PTK uses a 193nm excimer laser to break molecular bonds between cells on the epithelial surface. It is considered a more reliable, safe, and precise alternative to manual debridement, completely obliterating the basement membrane and potentially reducing recurrence rates. Success rates without recurrence range from 46% to 100%, with minimal complications. Unlike manual debridement, PTK may induce a hyperopic shift, which stabilizes within a year. Corneal erosions and pain recur at about 13% over an average of 9.7 months. Comparative studies between these two methods are scarce, and more data is needed to favor one technique over the other. Limited comparisons suggest PTK results are comparable to manual debridement, though shorter follow-ups in MD patients may underestimate associated complications. Our study aims to compare these techniques to describe the efficacy and safety of both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual debridement | Active comparator | Procedure: Manual debridementManual debridement is a technique that has existed since 1952 and whose objective is to remove the irregular epithelium by scraping with an instrument, thus allowing the formation of a new superficial layer. Some surgeons use 20% ethanol which they apply to the cornea to debride it before using a blade or sponge to complete the procedure. In this technique, the basement membrane is preserved. This method is still used being simple and cost effective. Its effectiveness in the treatment of recurrent corneal erosions is demonstrated by a success rate estimated at 85%. Thus, it is one of the methods of treating epithelial basement membrane dystrophy. However, the recurrence rate associated with manual debridement is up to 24%, and the average duration before a first recurrence is estimated at 6 months. The formation of corneal opacities was recorded between 7 and 41 days following the intervention. |
| Phototherapeutic keratectomy | Experimental | Procedure: Phototherapeutic keratectomyOver the past two decades, phototherapeutic keratectomy (PTK) has become an increasingly used approach for the treatment of several anterior corneal pathologies, including epithelial basement membrane dystrophy. This technique consists of directing a 193nm excimer laser towards the epithelial surface in order to break the molecular bonds between cells. PTK appears to be a more reliable, safe and precise alternative to manual debridement. Unlike manual debridement, PTK completely obliterates the basement membrane which would promote a reduction in the recurrence rate according to some experts. Thus, the success rate without recurrence has been estimated between 46 to 100% by certain studies and the associated complications are minimal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years of age;
- Ability to give free and informed consent
- At least 1-year follow-up possible
- Patients with bilateral basal membrane corneal dystrophy who are symptomatic (recurrent corneal erosions, visual disturbances) and are candidates for bilateral surgery.
Key exclusion criteria (2 listed)
- Patient under 18 years of age;
- History of ocular infection with herpes simplex virus.
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 |
|---|---|---|
| Manual debridementTraditional technique which consists of scraping off the irregular epithelium to allow a new layer to form. | Procedure or surgery | Manual debridement |
| Phototherapeutic keratectomyNew technique which has been increasingly used and which consists of a 193nm excimer laser that breaks molecular bonds between cells on the epithelial surface. | Procedure or surgery | Phototherapeutic keratectomy |
Primary outcome
The recurrence rate of corneal basement membrane dystrophy
Time frame: Day 1, week 1 and months 1, 3, 6, 12 and 24 months
Evaluated with slit-lamp morphological findings (maps, "fingerprint" lines, epithelial microcysts), imaging results including OCT (thickened basement membrane and epithelial irregularities) and patient symptoms (redness, pain, photophobia, associated with erosions).
5 secondary outcomes
Corneal haze formation assessed by a corneal haze gradation scale
Time frame: 1, 3, 6, 12 and 24 months
Contrast sensitivity with the CSV-1000 Contrast Sensitivity chart with glare
Time frame: 1,3,6,12 and 24 months
Patient comfort using the Wong-Baker FACES pain scale
Time frame: Day 1, week 1, month 1, month 3, month 6 and month 12
Post-operative complications
Time frame: Day 1, week 1, month 1, month 3, month 6 and month 12
Best corrected distance visual acuity (BCVA)
Time frame: 1,3,6,12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Results publication: PubMed 28031698Lee WS, Lam CK, Manche EE. Phototherapeutic keratectomy for epithelial basement membrane dystrophy. Clin Ophthalmol. 2016 Dec 16;11:15-22. doi: 10.2147/OPTH.S122870. eCollection 2017.
- Results publication: PubMed 17068452Pogorelov P, Langenbucher A, Kruse F, Seitz B. Long-term results of phototherapeutic keratectomy for corneal map-dot-fingerprint dystrophy (Cogan-Guerry). Cornea. 2006 Aug;25(7):774-7. doi: 10.1097/01.ico.0000214801.02195.d4.
- Results publication: PubMed 27722758Gaster RN, Ben Margines J, Gaster DN, Li X, Rabinowitz YS. Comparison of the Effect of Epithelial Removal by Transepithelial Phototherapeutic Keratectomy or Manual Debridement on Cross-linking Procedures for Progressive Keratoconus. J Refract Surg. 2016 Oct 1;32(10):699-704. doi: 10.3928/1081597X-20160712-01.
- Results publication: PubMed 33229661Deshmukh R, Reddy JC, Rapuano CJ, Vaddavalli PK. Phototherapeutic keratectomy: Indications, methods and decision making. Indian J Ophthalmol. 2020 Dec;68(12):2856-2866. doi: 10.4103/ijo.IJO_1524_20.
- Results publication: PubMed 35321046Yeu E, Hashem O, Sheha H. Treatment of Epithelial Basement Membrane Dystrophy to Optimize the Ocular Surface Prior to Cataract Surgery. Clin Ophthalmol. 2022 Mar 15;16:785-795. doi: 10.2147/OPTH.S356421. eCollection 2022.
- Results publication: PubMed 33237913Buffault J, Zeboulon P, Liang H, Chiche A, Luzu J, Robin M, Rabut G, Labetoulle M, Labbe A, Baudouin C. Assessment of corneal epithelial thickness mapping in epithelial basement membrane dystrophy. PLoS One. 2020 Nov 25;15(11):e0239124. doi: 10.1371/journal.pone.0239124. eCollection 2020.
- 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.
Marie-Catherine Tessier, M.Sc. contact
Samir Jabbour, MD,CM,FRCSC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual debridement and Phototherapeutic keratectomy in people with Epithelial Basement Membrane Dystrophy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Jul 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samir Jabbour, MD,CM,FRCSC (514-890-8000 ext. 11550, Samir.Jabbour.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence rate of corneal basement membrane dystrophy (time frame: Day 1, week 1 and months 1, 3, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06618508, which also lists 6 linked publications.
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 8 Jul 2026.