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

25 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for map-dot-fingerprint dystrophy?

Research shows that phototherapeutic keratectomy (PTK) is effective for treating map-dot-fingerprint dystrophy, as it helps improve vision and reduce symptoms like recurrent corneal erosion (a condition where the outer layer of the eye's surface repeatedly breaks down). PTK is considered a gold standard treatment for this condition, indicating its strong effectiveness. ^{1 2 3 4 5}

Is phototherapeutic keratectomy safe for treating map-dot-fingerprint dystrophy?

Phototherapeutic keratectomy (PTK) is generally considered safe for treating map-dot-fingerprint dystrophy, as it is a minimally invasive procedure that has been used successfully in various studies for this condition. ^{1 2 3 4 5}

How does the treatment for map-dot-fingerprint dystrophy differ from other treatments?

Phototherapeutic keratectomy (PTK) is a unique treatment for map-dot-fingerprint dystrophy because it uses an excimer laser to precisely remove the affected corneal tissue, which can improve vision and reduce recurrent corneal erosion. This method is considered the gold standard for this condition, offering a minimally invasive alternative to manual debridement, which involves physically scraping the cornea. ^{1 2 3 5 6}

What is the purpose of this trial?

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.

Research Team

Samir Jabbour, MD,CM,FRCSC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term results of phototherapeutic keratectomy for corneal map-dot-fingerprint dystrophy (Cogan-Guerry). [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Phototherapeutic keratectomy for the treatment of Cogan's microcystic dystrophy]. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Phototherapeutic keratectomy versus alcohol epitheliectomy with mechanical debridement for superficial variant of granular dystrophy: a paired eye comparison. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Phototherapeutic keratectomy (PTK) for treatment of recurrent corneal erosion: Correlation between etiology and prognosis - prospective longitudinal study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Phototherapeutic keratectomy for epithelial basement membrane dystrophy : Impact of excimer laser systems used on the changes of visual acuity, refraction and astigmatism]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Pathogenesis and treatment of recurrent erosion. [2019]