Manual Debridement Vs Phototherapeutic Keratectomy in the Treatment of Corneal Basement Membrane Dystrophy

NCT06618508 | Not Yet Recruiting

• 1 other identifier: 2024-12106
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. Our study, therefore, aims to offer a comparison between these two techniques to clarify the choice of effective treatment with a good safety profile.

Conditions

Epithelial Basement Membrane Dystrophy

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  1, 3, 6, 12 and 24 months

• Contrast sensitivity with the CSV-1000 Contrast Sensitivity chart with glare

  1,3,6,12 and 24 months

• Patient comfort using the Wong-Baker FACES pain scale

  Day 1, week 1, month 1, month 3, month 6 and month 12

• Post-operative complications

  Day 1, week 1, month 1, month 3, month 6 and month 12

• Best corrected distance visual acuity (BCVA)

  1,3,6,12 and 24 months

Study Arms (2)

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.

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.

Procedure: Phototherapeutic keratectomy

Interventions

Manual debridement PROCEDURE

Traditional technique which consists of scraping off the irregular epithelium to allow a new layer to form.

Manual debridement

Phototherapeutic keratectomy PROCEDURE

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.

Phototherapeutic keratectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient under 18 years of age;
• History of ocular infection with herpes simplex virus.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (6)

• 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.

  PMID: 28031698 BACKGROUND

• Pogorelov 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.

  PMID: 17068452 BACKGROUND

• Gaster 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.

  PMID: 27722758 BACKGROUND

• Deshmukh 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.

  PMID: 33229661 BACKGROUND

• Yeu 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.

  PMID: 35321046 BACKGROUND

• Buffault 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.

  PMID: 33237913 BACKGROUND

MeSH Terms

Conditions

Corneal dystrophy, epithelial basement membrane

Study Officials

• Samir Jabbour, MD,CM,FRCSC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samir Jabbour, MD,CM,FRCSC

CONTACT

514-890-8000; Samir.Jabbour.med@ssss.gouv.qc.ca

Marie-Catherine Tessier, M.Sc.

CONTACT

514-890-8000; marie-catherine.tessier.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Samir Jabbour

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)