Comparison of Efficacy and Safety Between Manual Debridement and Phototherapeutic Keratectomy (PTK) in the Treatment of Corneal Basement Membrane Dystrophy
Sponsor study identifier
Secondary identifiers
NIH
interventional
25
1 country
1
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2024
Actual (reported)October 1, 2024
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
Traditional technique which consists of scraping off the irregular epithelium to allow a new layer to form.
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.
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
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.
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.
Samir Jabbour, MD,CM,FRCSC
Centre hospitalier de l'Université de Montréal (CHUM)
First Submitted
September 26, 2024
First Posted
October 1, 2024
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2027
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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.
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.
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.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 8, 2026
Record last verified: 2026-07
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