Clinical trial NCT06618508: Manual Debridement Vs Phototherapeutic Keratectomy in the Treatment of Corneal Basement Membrane Dystrophy
Official title: Comparison of Efficacy and Safety Between Manual Debridement and Phototherapeutic Keratectomy (PTK) in the Treatment of Corneal Basement Membrane Dystrophy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epithelial Basement Membrane Dystrophy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: The recurrence rate of corneal basement membrane dystrophy
timeFrame: Day 1, week 1 and months 1, 3, 6, 12 and 24 months
Secondary outcomes:
measure: Corneal haze formation assessed by a corneal haze gradation scale
timeFrame: 1, 3, 6, 12 and 24 months
measure: Contrast sensitivity with the CSV-1000 Contrast Sensitivity chart with glare
timeFrame: 1,3,6,12 and 24 months
measure: Patient comfort using the Wong-Baker FACES pain scale
timeFrame: Day 1, week 1, month 1, month 3, month 6 and month 12
measure: Post-operative complications
timeFrame: Day 1, week 1, month 1, month 3, month 6 and month 12
measure: Best corrected distance visual acuity (BCVA)
timeFrame: 1,3,6,12 and 24 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Samir Jabbour, MD,CM,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.