Manual Debridement vs Phototherapeutic Keratectomy for Map-Dot-Fingerprint Dystrophy

Overseen By Marie-Catherine Tessier, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Under 18, Herpes simplex, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for map-dot-fingerprint dystrophy, a condition causing eye problems such as recurring corneal erosions and vision issues. It compares manual debridement, a scraping technique that removes the irregular top layer of the eye, with phototherapeutic keratectomy (PTK), a laser treatment that targets and removes problematic tissues. Researchers aim to determine which method is more effective and safer in the long run. Individuals with ongoing symptoms from this eye condition who plan to have surgery on both eyes might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to explore new treatment options and contribute to advancing eye care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these techniques are safe for treating Map-Dot-Fingerprint Dystrophy?

Research has shown that both manual debridement and phototherapeutic keratectomy (PTK) are safe treatments for map-dot-fingerprint dystrophy.

Manual debridement achieves a success rate of about 85% for this condition. However, the condition may return, with a recurrence rate of up to 24%. Some patients notice cloudy spots on their eyes within a month after the procedure. Despite this, it remains a simple and cost-effective method used for many years.

PTK, in contrast, is a more modern treatment that uses a laser for precision and fewer complications. Some studies suggest it may reduce the recurrence of the condition more effectively than manual debridement. The success rate for PTK without recurrence ranges from 46% to 100%, depending on the study.

Both treatments are generally well-tolerated, but each has its own potential risks and benefits. Consulting a healthcare professional is essential to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about phototherapeutic keratectomy (PTK) for map-dot-fingerprint dystrophy because it uses a precise 193nm excimer laser to break molecular bonds between corneal cells. Unlike manual debridement, which involves scraping the surface and preserving the basement membrane, PTK completely removes the basement membrane. This difference may lead to a lower recurrence rate of corneal erosions. Additionally, PTK offers a more reliable and safe approach, with fewer complications, making it a promising alternative to older methods.

What evidence suggests that these techniques are effective for treating Map-Dot-Fingerprint Dystrophy?

This trial will compare Manual Debridement with Phototherapeutic Keratectomy (PTK) for treating epithelial basement membrane dystrophy. Studies have shown that manually removing damaged tissue is effective, achieving about an 85% success rate, though the condition can return in up to 24% of cases, often within six months. In this trial, some participants will undergo Manual Debridement, while others will receive PTK. PTK uses a laser to remove the affected tissue and has a reported success rate between 46% and 100%, depending on the study. Experts consider PTK more precise and safer, suggesting it may lower the chance of recurrence by completely removing the problem area. Overall, PTK appears to be a reliable alternative to manual removal, with fewer complications. ^{1 2 3 6 7}

Who Is on the Research Team?

Samir Jabbour, MD,CM,FRCSC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for individuals with Cogan Syndrome or Map-dot-fingerprint dystrophy, which are conditions affecting the cornea of the eye. Participants should have a diagnosis of these conditions to be eligible.

Inclusion Criteria

Ability to give free and informed consent

At least 1-year follow-up possible

I am over 18 years old.

Exclusion Criteria

History of ocular infection with herpes simplex virus.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either manual debridement or phototherapeutic keratectomy to treat corneal basement membrane dystrophy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of corneal basement membrane dystrophy and other outcomes

24 months

Visits at Day 1, Week 1, and Months 1, 3, 6, 12, and 24

What Are the Treatments Tested in This Trial?

Interventions

• Manual debridement
• Phototherapeutic keratectomy

Trial Overview The study compares two treatments for corneal basement membrane dystrophy: manual debridement (MD) and phototherapeutic keratectomy (PTK). It aims to determine which treatment is more effective and has fewer complications over time.

How Is the Trial Designed?

Group I: Phototherapeutic keratectomy Experimental Treatment 1 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.

Group II: Manual debridement Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939407003947

Outcomes of Epithelial Debridement for Anterior Basement ... Purpose. To evaluate the outcomes of simple mechanical debridement for the management of anterior basement membrane dystrophy (ABMD) in a cohort of patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17553446/

Outcomes of epithelial debridement for anterior basement ... Conclusions: Our results with this simple technique are comparable to outcomes reported with other procedures used to treat ABMD. We recommend manual ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06618508

Manual Debridement Vs Phototherapeutic Keratectomy in ... Its effectiveness in the treatment of recurrent corneal erosions is demonstrated by a success rate estimated at 85%. Thus, it is one of the ...

4. webeye.ophth.uiowa.edu webeye.ophth.uiowa.edu/eyeforum/cases/78-EBMD-treatment.htm

Treatment of Epithelial Basement Membrane Dystrophy With ... In the present study, we reviewed the outcome of treating symptomatic Epithelial Basement Membrane Dystrophy with manual Superficial ...

5. ajo.com ajo.com/article/S0002-9394(07)00394-7/abstract

Outcomes of Epithelial Debridement for Anterior Basement ... Purpose. To evaluate the outcomes of simple mechanical debridement for the management of anterior basement membrane dystrophy (ABMD) in a cohort ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642010007189

Clinical Outcome and Recurrence of Epithelial Basement ... Although PTK is an effective method of alleviating the clinical symptoms of EBMD, the dystrophy can recur with time. The relationship between the postoperative ...

7. reviewofoptometry.com reviewofoptometry.com/article/when-should-you-treat-ebmd-with-ptk

When Should You Treat EBMD with PTK? Phototherapeutic keratectomy (PTK) in the treatment of EBMD and RCE can successfully eliminate the need for a more traumatic or invasive treatment plan.