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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions

NCT01251692

Recurrent Corneal Erosions

COMPLETED PHASE4

The Debridement To Treat The Traumatic Corneal Abrasion

NCT05534217

Corneal Abrasion

UNKNOWN NA

Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

NCT06070883

Keratitis

COMPLETED NA

Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

NCT01237600

Severe Ocular Surface Damage Limbal Deficiency

COMPLETED PHASE2/PHASE3

Comparison Between Bare Scleral Technique and Conjunctival Auto-graft on Corneal Topography After Pterygium Surgery

NCT05812508

Corneal Topography

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epithelial Basement Membrane Dystrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual debridement

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.

Group Type ACTIVE_COMPARATOR

Manual debridement

Intervention Type PROCEDURE

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

Phototherapeutic keratectomy

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 Type EXPERIMENTAL

Phototherapeutic keratectomy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual debridement

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

Intervention Type PROCEDURE

Phototherapeutic keratectomy

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.