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临床试验/NCT06618508
NCT06618508尚未招募不适用

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

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
The recurrence rate of corneal basement membrane dystrophy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Patient under 18 years of age;
  • •History of ocular infection with herpes simplex virus.

研究组 & 干预措施

Manual debridement

Active Comparator

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.

干预措施: Manual debridement (Procedure)

Phototherapeutic keratectomy

Experimental

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.

干预措施: Phototherapeutic keratectomy (Procedure)

结局指标

主要结局

The recurrence rate of corneal basement membrane dystrophy

时间窗: 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).

次要结局

  • Corneal haze formation assessed by a corneal haze gradation scale(1, 3, 6, 12 and 24 months)
  • Contrast sensitivity with the CSV-1000 Contrast Sensitivity chart with glare(1,3,6,12 and 24 months)
  • Patient comfort using the Wong-Baker FACES pain scale(Day 1, week 1, month 1, month 3, month 6 and month 12)
  • Post-operative complications(Day 1, week 1, month 1, month 3, month 6 and month 12)
  • Best corrected distance visual acuity (BCVA)(1,3,6,12 and 24 months)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor
主要研究者

Samir Jabbour

Dr Samir Jabbour

Centre hospitalier de l'Université de Montréal (CHUM)

研究点 (1)

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