Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 18
- 主要终点
- Difference in analgesic consumption between patients treated with a therapeutic lens + amniotic membrane (experimental) and patients treated with a therapeutic lens alone (active comparator)
研究概览
简要总结
Crosslinking is a therapeutic technique used to increase the rigidity of the cornea in order to slow or stop progression of keratoconus. The main complication of the treatment of keratoconus by crosslinking is postoperative pain due to the removal of the corneal epithelium. Currently, the management of pain is done through the administration of artificial tears and paracetamol. The amniotic membrane is a biological tissue used in ophthalmology to treat injuries of the surface of the eye. It has healing and analgesic properties.
The objective of this multicenter randomized study is to evaluate the benefit of placing an amniotic membrane on the eye post-crosslinking to reduce pain and promote corneal healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman between 18 and 65 years old.
- •Indication for accelerated conventional crosslinking.
- •Patient with progressive keratoconus (increase in Kmax of ≥ 0.5 diopters in 3 to 6 months or ≥ 1 diopter in 3 to 12 months with loss of 10 microns on minimum pachymetry in 3 to 12 month).
- •Patient suffering from keratoconus with a compatible topographic form (Kmax ≥ 47.0 diopters (D) and difference inferior-superior of 1.5 D).
- •Patient with a minimum corneal thickness greater than 400 microns.
- •Informed and consenting patient.
- •Patient physically and mentally capable of completing the post-operative pain assessment self-questionnaire.
- •Patient having signed the informed consent of the French Ophthalmology Society for crosslinking.
- •Patient affiliated to a social security system or beneficiary of such a system.
排除标准
- •Woman without effective means of contraception, pregnant or breastfeeding.
- •Patient who has already benefited from a crosslinking procedure on one of the eyes.
- •Patient with a history of refractive surgery on one of the eyes.
- •Patient with an intracorneal ring segment on one of the eyes.
- •Patient suffering from a serious systemic pathology (autoimmune and/or immunodepressive)
- •Patient with a psychiatric pathology.
- •Patient on long-term analgesics and/or corticosteroids.
- •Indication of crosslinking outside the classic protocol.
- •Patient with central corneal opacity.
- •Patient suffering from a severe dry eye syndrome or a neurotrophic keratitis.
- •Patient with a history of ocular herpes.
- •Patient with a history of ocular varicella-zoster virus infection.
- •Patient with glaucoma.
- •Patient treated with topical cyclosporine in the last 6 months.
- •Patient deprived of liberty by a judicial or administrative decision.
- •Patient subject to a legal protection measure or unable to express their consent.
结局指标
主要结局
Difference in analgesic consumption between patients treated with a therapeutic lens + amniotic membrane (experimental) and patients treated with a therapeutic lens alone (active comparator)
时间窗: Day 0, Day 1, Day 2
Amount in grams of analgesic consumed per day
Difference between the level of ocular pain experienced by patients treated with therapeutic lens + amniotic membrane (experimental) and by patients treated with therapeutic lens alone (active comparator)
时间窗: Day 0 bedtime, Day 1 wake-up, Day 1 bedtime, Day 2 wake-up, Day 2 consultation
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
次要结局
- Difference in visual acuity between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)(Week 6)
- Difference in topographic parameters (Kmax, inferior-superior) between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)(Week 6)
- Difference in dryness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)(Week 6)
- Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)(Day 2, (Day 7), Week 6)
- Difference in corneal thickness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)(Week 6)