Epithelial Basement Membrane Dystrophy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The recurrence rate of corneal basement membrane dystrophy | 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
| Measure | Time frame | Description |
|---|---|---|
| Corneal haze formation assessed by a corneal haze gradation scale | 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. 1. Haze of minimal density seen with difficulty with direct or diffuse examination. 2. Mild haze easily visible with direct focal slit lamp illumination. 3. Moderate opacity that partially obscured details of iris. 4. Severe opacity that completely obscured the details of intraocular structures. |
| Contrast sensitivity with the CSV-1000 Contrast Sensitivity chart with glare | 1,3,6,12 and 24 months | Standardized contrast sensitivity test. |
| Patient comfort using the Wong-Baker FACES pain scale | 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 |
| Post-operative complications | 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. |
| Best corrected distance visual acuity (BCVA) | 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. |
Countries
Canada
Contacts
Centre hospitalier de l'Université de Montréal (CHUM)