Anatomical and Visual Outcomes of Retinal Re-suregries in Silicone Oil Filled Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity as assessed by LogMAR (Logarithm Minimum Angle of Resolution) chart
研究概览
简要总结
Anatomical and Visual outcomes of retinal re-surgeries done in silicone oil filled eyes
详细描述
- Basic demographic profile including Name, Age, Gender, Place of Residence will be documented.
- structured questionnaire will be used to collect information regarding systemic diseases including Diabetes mellitus and its duration, Hypertension, Dyslipidemia , any cardiovascular diseases, any history of ocular trauma or any other ocular comorbidities.
- Details of the primary retinal surgery including indication, date of surgery, Name of the procedure will be noted
- Details of re surgery including indication (retinal pathology), timing of the re surgery from the primary surgery, preoperative Best Corrected Visual Acuity(BCVA) A using log MAR (Minimum Angle of resolution)) chart at 3 meters, intra ocular pressure using non contact Reichert 7 tonometry will be noted.
- Slit lamp bio-microscopy of the anterior segment using Topcon slit lamp biomicroscope,90 Diopter lens examination and indirect ophthalmoscopy with 20 Diopter lens of the fundus will be done.
- Spectral domain OCT(Optical coherence Tomography) with Zeiss Cirrus HD OCT (High Definition- Optical Coherence tomography) machine will be done for documentation of the status of macula in whichever cases possible.
- Re surgery will be done by a single Senior consultant in all the cases. Alcon Luxor Biomicroscope with Non contact BIOM (binocular indirect ophthalmomicroscope ) viewing system will be used. 2 ports will be made. Top up of Silicone oil will be done whenever needed. Membrane peeling with relaxing retinectomy / drainage retinotomy , haemostasis and endolaser will be done under Silicone oil as required. After the re surgery, the patient will be advised to maintain prone position.
- After the re surgery the BCVA(Best Corrected Visual Acuity), IOP (Intraocular pressure) will be noted on first visit at 15 days, 3rd month and 6th month follow up.
- Fundus examination will be done at all visits. Spectral Domain OCT(Optical coherence Tomography) will be done at all visits to see the status of macula.
STATISTICAL ANALYSIS
- Data entry will be done in Microsoft excel and analysed using the latest SPSS (Statistical Package for the Social Sciences) software.
- Wherever required, descriptive analysis will be done
- Chi square test will be used to find the statistical significance among the qualitative data, •two-tail t test will be used to find statistical significance among the quantitative data pre and post operatively.
- Other statistical tests will be used depending upon the need for post hoc analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had under gone the primary retina surgery at Ahalia Foundation Eye Hospital / elsewhere for retinal detachment secondary to various retinal pathologies and underwent re surgery during their follow up at Ahalia Foundation Eye Hospital during the study period.
- •Patients whose proper follow up to 6 months after re surgery were maintained during the study period.
- •No history of any additional eye disease other than h/o cataract surgery or primary RD repair.
- •Patients who were willing to be a part of the study and willing to provide informed written consent.
排除标准
- •Patients who did not come for any of the follow up included in the study.
- •Patients who had history of ocular trauma after the primary surgery.
- •Patients who have any other ocular comorbidities other than cataract.
- •Patients who had undergone multiple previous re surgeries for retinal detachment.
结局指标
主要结局
Change in Best Corrected Visual Acuity as assessed by LogMAR (Logarithm Minimum Angle of Resolution) chart
时间窗: 6 months after Resurgery; 1 month post Silicone oil removal in eyes undergoing silicone oil removal
* Change in mean Best Corrected Visual Acuity from Pre-operative time to 6 months post Re-surgery in silicone oil filled eyes * Change in mean Best Corrected Visual Acuity from Pre-operative time to 6 months post Re-surgery in silicone oil filled eyes with primary diagnosis of Diabetic Macular Tractional detachment * Change in mean Best Corrected Visual Acuity from Pre-operative time to 6 months post Re-surgery in silicone oil filled eyes with primary diagnosis of Rhegmatogenous retinal detachment * Change in mean Best Corrected Visual Acuity from Pre-operative time to 1month post Silicone oil Removal in eyes undergoing Silicone oil removal after Re-surgery in silicone oil filled eyes
Number and Percentage of eyes with Retina Reattched after resurgery in Silicone oil filled eyes
时间窗: •6 months post resurgery; •3 months post silicone oil removal in Patients who underwent silicone oil removal
* Total Number and Percentage of eyes with Retina Re-attached after re-surgery in Silicone oil filled eyes * Number and Percentage of eyes with Retina Re-attached after re-surgery in Silicone oil filled eyes having primary diagnosis of Diabetic Macular Tractional Detachment * Number and Percentage of eyes with Retina Re-attached after re-surgery in Silicone oil filled eyes having primary diagnosis of Rhegmatogenous retinal Detachment * Number and Percentage of eyes after re-surgery in Silicone oil filled eyes who underwent Silicone oil removal later * Number and Percentage of eyes who had retinal re-detachment after undergoing Silicone oil removal later
次要结局
- number and percentage of patients having Best Corrected Visual Acuity of 1.6 Log Units(6 months)
- Number and percentage of eyes/patients having various risk factors for retinal detachment after primary surgery in silicone oil filled eyes(6 months)
- Number and percentage of eyes/patients with adverse events intraoperative and post re-surgery in silicone oil filled eyes(6 months post resurgery; 3 months post Silicone oil removal)
- IOP change post Retinal Resurgery in silicone oil filled eyes(6 months)
研究者
Dr. Saurav Mahajan
Principal Investigator, Clinical Professor Adjunct
Ahalia Foundation Eye Hospital