Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Best spectacle corrected visual acuity
研究概览
简要总结
Surgical treatment of corneal endothelial decompensation in the presence of an anterior chamber intraocular lens (AC IOL) is technically challenging. The ultimate management is to perform Descemet membrane endothelial keratoplasty (DMEK). However , unfolding the DMEK graft in the presence of an AC IOL can be difficult and injurious to the graft so the investigators recommend exchanging the AC IOL with a posterior chamber IOL first. In this study , the investigators aim to compare the outcome and complications of performing DMEK and IOL exchange as combined one stage surgery versus .sequential 2 stage procedure
详细描述
Pseudophakic Bullous keratopathy is the second leading indication for endothelial keratoplasty. One of the main controversies in the management of PBK in the presence of an AC IOl is whether to retain the IOL or perform an IOL exchange with a PC IOL. The investigators believe that retention of an AC IOL can be hazardous to the DMEK graft due to reduced depth of the anterior chamber and traumatic touch between the graft and the IOL during graft unfolding and even postoperatively. On the other hand , performing an IOL exchange is relatively time consuming and requires excess manipulation of the iris tissue with the risk of intraoperative hyphema and postoperative inflammation which can affect the endothelial graft survival and cell count.
Aim of the study : to compare the outcome and complications between performing intraocular lens (IOL) exchange and Descemet membrane endothelial keratoplasty (DMEK) as single stage versus two stage procedure in the management of pseudophakic bullous keratopathy associated with anterior chamber IOL.
Methods :
The study will be a prospective randomized controlled trial. Eligible subjects with pseudophakic bullous keratopathy and AC IOL will be assigned into two groups each comprising 10 eyes. One group will undergo AC IOL exchange with posterior chamber (PC) IOL ( Poly methyl methacrylate (PMMA) lens or iris claw lens if there is no adequate capsular support) combined with DMEK in the same setting. The other group will undergo 2 stage procedure ; first one is IOL exchange , iridoplasty (if required) and inferior peripheral iridectomy and the second stage is DMEK one month later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens.
- •Age above 18 years old.
排除标准
- •Patients with corneal stromal scarring .
- •Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.
结局指标
主要结局
Best spectacle corrected visual acuity
时间窗: 3 months
best spectacle corrected visual acuity using the decimal system
Postoperative AC inflammatory reactions
时间窗: 1 month postoperatively
postoperative AC inflammatory reactions including cell and flare will be determined by slit lamp examination under high magnification: AC cells will be graded according to the Standardization of Uveitis Nomenclature (SUN) group grading system as following : Grade 0 : 5 or less cells in 1\*1mm slit beam Grade 1 : 6- 15 cells in 1\*1mm slit beam Grade II : 16-25 cells in 1\*1mm slit beam Grade III : 26-50 cells in 1\*1mm slit beam grade IV : more than 50 cells in 1\*1mm slit beam . AC flare will be graded according to the SUN grading system : Grade 0 : none Grade I : faint Grade II : moderate ( iris and lens details still seen ) Grade III : Marked ( iris and lens details hazy) Grade IV : intense ( fixed and plastic aqueous ).
postoperative hyphema and and intraocular pressure spikes
时间窗: 1month postoperatively
Any postoperative hyphema and anterior chamber inflammatory reactions will determined by slit lamp examination: Hyphema if found will be graded into : 1. Microscopic hyphema : circulating red blood cells in the AC 2. Grade I : less than one third the AC 3. Grade II: one third to one half the AC 4. Grade III: more than one half the AC but not total 5. Grade IV : total hyphema. and intraocular pressure spikes will detected using the Goldmann applanation tonometer to measure the intraocular pressure in mmHg
postoperative endothelial cell loss in percentage
时间窗: 3 months
The postoperative endothelial cell count will be determined in cell/mm2 using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA) at 3 months and compared to the preoperative endothelial cell count of the donor graft to calculate the percentage of endothelial cell loss
Postoperative intraocular pressure spikes
时间窗: 1 month postoperatively
postoperative intracular pressure will be measured by Goldmann Applanation Tonometer in mmHg
次要结局
- Spherical equivalent(3 months postoperatively)
- Keratometric values(3 months)
- central corneal thickness(3 months postoperatively)
- graft detachment(1 week postoperatively)
研究者
Mohamed Kolaib
Ophthalmology resident
Alexandria University