Fovea Sparing ILM Peeling vs Complete ILM Peeling in Diabetic Patients With Proliferative Diabetic Retinopathy (PDR) Indicated for Pars Plana Vitrectomy (PPV).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Functional outcome
研究概览
简要总结
The goal of this clinical trial is to compare between foveal sparing ILM peeling and total ILM peeling in diabetic patients (both type 1 and II) with proliferative diabetic retinopathy (PDR) indicated for pars plana vitrectomy (PPV) on functional and anatomical outcomes regarding postoperative best corrected visual acuity (BCVA), measuring central subfield thickness and evaluation of morphology and integrity of inner retinal layers (including vitreoretinal interface) and the outer retinal layers (especially the ellipsoid zone) using macular OCT.
Researchers will compare compare between foveal sparing internal limiting membrane (ILM) peeling and total ILM peeling in diabetic patients indicated for PPV on functional and anatomical outcomes regarding postoperative BCVA, and integrity of inner and the outer retinal layers using macular OCT.
Participants will:
- Undergo preoperative full ophthalmic examination, routine labs and investigations and OCT macula if media allows visualization of the macula to evaluate the vitreoretinal interface and vitreomacular traction (VMT) macular edema, obtain the central subfield thickness and to assess the integrity of the ellipsoid zone.
- Undergo surgery (PPV) with either foveal sparing ILM peeling or total ILM peeling.
- Visit the clinic postoperatively for follow-up at 1-day, 1-week, 1-month, 3-months and 6-months intervals to undergo complete slit lamp examination, and fundus examination using slit lamp biomicroscoby. measure BCVA
- Undergo OCT macula at 1,3 and 6 months postoperatively to obtain central subfield thickness (CST) and to evaluate morphology and integrity of inner retinal layers (including vitreoretinal interface) and the outer retinal layers (especially the ellipsoid zone).
详细描述
● Study: Foveal sparing ILM peeling versus complete ILM peeling in diabetic patients indicated for Pars Plana Vitrectomy (comparative study).
● Background and Rationale: .Diabetic retinopathy significantly affects vision nationally and globally. .Proliferative diabetic retinopathy (PDR) is characterized by the growth of new vessels on the retina or the optic disc, leading to vitreous hemorrhage, tractional retinal detachment, rubeosis iridis, and eventually blindness.
.Panretinal photocoagulation has been the treatment for PDR since the 1970s. However, chronic vitreous hemorrhage, tractional, or combined tractional-rhegmatogenous retinal detachments are indications for early vitrectomy.
Some surgeons peel the internal limiting membrane (ILM) after staining to prevent epimacular reproliferation (although not mandatory) aiming for better postoperative visual results. ILM peeling removes the scaffold for ERM proliferation, thereby decreasing recurrence due to traction on the macula.
.However, several potential detrimental effects on the inner retina have been demonstrated after ILM peeling and irregularities in the inner retinal surface.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients (both type 1 and II) with evident epiretinal membrane (ERM) and/or vitreo-macular traction (VMT)) inducing cystoid edema or foveoschisis detected either preoperatively or intraoperatively in cases with dense vitreous hemorrhage that can impair preoperative macular evaluation.
- •Visual acuity of HMGP or better.
排除标准
- •Any history of or pre-existing ocular pathology such as glaucoma, uveitis….etc.
- •History of previous RVO or RAO.
- •Systemic diseases with possible ocular involvement e.g. collagen vascular diseases.
结局指标
主要结局
Functional outcome
时间窗: 6 months from the surgery
comparing postoperative best corrected visual acuity (BCVA) between both groups
次要结局
- Anatomical outcome(6 months from the surgery)
研究者
David Nashaat Shafik Fahmy
Assistant lecturer of ophthalmology
Cairo University