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NCT Number: NCT06618508

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual debridement

Procedure

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

phototherapeutic keratectomy

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.

Primary outcomes

  1. The recurrence rate of corneal basement membrane dystrophy

    Time frame: Day 1, week 1 and months 1, 3, 6, 12 and 24 months

    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).

Secondary outcomes

  1. Corneal haze formation assessed by a corneal haze gradation scale

    Time frame: 1, 3, 6, 12 and 24 months

    0: Clear with no opacity seen by any method of microscopic slit-lamp examination.

    0.5: Trace or faint haze seen only by indirect, broad tangential illumination.

    • Haze of minimal density seen with difficulty with direct or diffuse examination.
    • Mild haze easily visible with direct focal slit lamp illumination.
    • Moderate opacity that partially obscured details of iris.
    • Severe opacity that completely obscured the details of intraocular structures.
  2. Contrast sensitivity with the CSV-1000 Contrast Sensitivity chart with glare

    Time frame: 1,3,6,12 and 24 months

    Standardized contrast sensitivity test.

  3. Patient comfort using the Wong-Baker FACES pain scale

    Time frame: Day 1, week 1, month 1, month 3, month 6 and month 12

    0 = no hurt; 2= hurts a little bit; 4=hurts little more; 6=hurts even more; 8=hurts whole lot; 10=hurts worst

  4. Post-operative complications

    Time frame: Day 1, week 1, month 1, month 3, month 6 and month 12

    Post-operative complications include persistent epithelial deficits, formation of subepithelial corneal opacities, infectious keratitis, reactivation of herpes simplex virus, scarring, and corneal infiltrates.

  5. Best corrected distance visual acuity (BCVA)

    Time frame: 1,3,6,12 and 24 months

    This is the visual acuity measured using an eye chart. To achieve best possible visual acuity, corrective lenses are used.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Catherine Tessier, M.Sc.

CONTACT

[email protected]

514-890-8000 ext. 11550

Samir Jabbour, MD,CM,FRCSC

CONTACT

[email protected]

514-890-8000 ext. 11550

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Comparison of Efficacy and Safety Between Manual Debridement and Phototherapeutic Keratectomy (PTK) in the Treatment of Corneal Basement Membrane Dystrophy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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