Comparative Effectiveness of PKP and DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced Bullous Pseudophakic Keratopathy: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 22
- 主要终点
- DSAEK and PKP comparison in terms of visual acuity
研究概览
简要总结
This is an open-label multicenter randomised controlled clinical trial with 2 parallel arms with a 1:1 ratio. Patients meeting the eligibility criteria will be offered to participate in the study during an ophthalmology consultation. If they agree, they are randomised into one of the 2 arms, surgery is scheduled, and baseline visual acuity, quality of life, patient satisfaction, pain level, and central corneal thickness are recorded (inclusion visit). The following visits involve: the corneal transplant procedure (DSAEK or PKP depending on the randomisation) and follow-up visits at 1, 6, 12, and 24 months. At each visit, visual acuity, patient satisfaction, pain level and complications will be determined. At 6, 12, and 24 months, endothelial cell density, central corneal thickness and required optical correction will be measured. At 12 and 24 months, quality of life, will also be determined.
详细描述
Bullous pseudophakic keratopathy (PBK) is the development of irreversible corneal edema after cataract surgery. Since approximately 20 million people worldwide undergo cataract surgery annually, and PBK can occur in 1-2% of cataract operations, PBK remains a major indication for corneal transplantation. Indeed, it accounts for a quarter of the 5,000 corneal transplant operations that are conducted in France each year. Penetrating keratoplasty (PKP) involves transplanting a full-thickness corneal button. It was the only corneal transplant technique available for PBK until 2004-2006, when two posterior lamellar corneal transplantation methods were invented and refined, namely, Descemet stripping automated keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). Both have transformed the management of PBK and are often preferred over PKP because of faster visual improvement and fewer complications, including astigmatism and graft rejection. This is particularly true for cases where preoperative visual acuity is better than 2/10 (0.7 logMAR). However, PKP is still indicated when visual acuity is below the ability to see hand movements (2 logMAR): in such cases, the severe stromal damage requires full-thickness transplantation. However, for PBK cases with intermediate visual acuity (i.e. between 0.7 and 2 logMAR), there is doubt about the best therapeutic solution. The relatively severe corneal damage in these cases is a contraindication for DMEK, which is a much more technically challenging procedure than DSAEK. Thus, the surgeon must choose either DSAEK or PKP. DSAEK is suitable for older people who mainly complain of eye pain: it is a simple and painless procedure that leads to satisfactory outcomes in 75% of cases. However, in the remaining 25% of patients, ocular pain may persist and/or the recovery of visual acuity is too limited and the patient is dissatisfied. In such cases, the patient is indicated for regraft with PKP. Given the poor visual outcomes of DSAEK for a substantial minority of patients with preoperative visual acuity between 0.7 and 2 logMAR, the present study asks whether PKP should be the primary choice for such patients. To improve decision-making for PBK, the study also asks whether it is possible to define preoperative visual acuity and/or central corneal thickness (CCT) thresholds that signal a high risk of regraft after primary DSAEK and therefore indicate a need for primary PKP.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient:
- •Is ≥ 50 years old.
- •Has advanced PBK, with a best corrected visual acuity that lies between being able to see a hand move (i.e. 2 logMAR, included) and 2/10 excluded (i.e. 0.7 logMAR, excluded) and a central corneal thickness that exceeds 600 μm.
- •Is indicated for a corneal transplant.
- •Is pseudophakic.
- •Has provided free and informed written consent.
- •Is affiliated to a social security scheme.
- •Can be followed-up by the same investigating team during the study period.
排除标准
- •The patient:
- •Has a history of corneal transplant on either eye (i.e. the study surgery will be the first corneal transplant for the patient).
- •Has an anterior chamber lens implant or is aphakic.
- •Has an ocular comorbidity that will impact visual acuity recovery: exudative or advanced atrophic AMD, advanced diabetic retinopathy (macular edema), advanced glaucoma (damage to the central visual field), important sequelae of central venous thrombosis of the retina or retinal detachment, previous amblyopia.
- •Has a contraindication to general anesthesia.
- •Is deprived of freedom, or under a legal protective measure.
- •Is included in another clinical study.
- •Has a severe general condition that might lead to premature discontinuation of the trial before the end of treatment period.
研究组 & 干预措施
DSAEK
DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's diseased endothelium and overlying Descemet membrane with a corneal graft composed of endothelium, Descemet membrane, and a thin layer of overlying stroma.
干预措施: Best corrected monocular visual acuity (Procedure)
PKP
PKP (Penetrating Keratoplasty) involves removing a full-thickness central corneal disc from the diseased cornea and replacing it with an equivalent corneal disc from a deceased human donor.
干预措施: Best corrected monocular visual acuity (Procedure)
结局指标
主要结局
DSAEK and PKP comparison in terms of visual acuity
时间窗: At 24 postoperative months
Best corrected monocular visual acuity (assessed with the Monoyer scale and expressed in logMAR)
次要结局
- Visual acuity(at 6, 12, and 24 postoperative months (repeated measures model))
- Time taken to achieve a postoperative best corrected visual acuity of at least 4/10 (0.4 logMAR).(up to 24 postoperative months)
- Percentage of patients achieving at least 4/10 (0.4 logMAR)(up to 24 postoperative months)
- Frequency of cases who require a regraft(up to 24 postoperative months)
- Complication number and types(within 24 postoperative months)
- Change in quality of life at 12 and 24 months relative to preoperative baseline(1 to 6 months before surgery and at 12 and 24 postoperative months)
- Patient satisfaction(at 1, 6, 12, and 24 postoperative months relative to preoperative baseline.)
- Pain level(at 1, 6, 12, and 24 postoperative months relative to preoperative baseline)
- Corneal endothelial cell density(at 6, 12, and 24 postoperative months.)
- Required optical correction(at 6, 12 and 24 postoperative months)
- Emerging adverse events and serious adverse events(with the 24 postoperative months)
- Change in central corneal thickness(at 6, 12 and 24 months relative to preoperative baseline)
- Graft thickness(at 6, 12, and 24 months in DSAEK arm relative to baseline)
- Scar dehiscence and major astigmatism in PKP arm, and graft detachment in DSAEK arm.(Within 24 postoperative months)
- Suture removal and corneal contact lens equipment in PKP arm(within 24 postoperative months)