Proliferative Diabetic Retinopathy, Proliferative Vitreo-Retinopathy, Retinal Detachment
Conditions
Keywords
Retinal Re-detachment, In silicone filled eyes, Under silicone oil, Proliferative Vitreoretinopathy
Brief summary
Anatomical and Visual outcomes of retinal re-surgeries done in silicone oil filled eyes
Detailed description
* 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.
Interventions
PROCEDUREResurgery In Silicone Oil Filled Eyes
* Alcon Luxor Biomicroscope with Non-contact BIOM (binocular indirect ophthalmomicroscope) viewing system was used. * 2 ports were made in Pars plana. * Top up of Silicone oil was done whenever needed. * Membrane peeling with relaxing retinectomy / drainage retinotomy, haemostasis and endolaser were done under Silicone oil as required. * After the re surgery, the patients were advised to maintain prone position.
Sponsors
Ahalia Foundation Eye Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity as assessed by LogMAR (Logarithm Minimum Angle of Resolution) chart | 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 | •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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number and percentage of patients having Best Corrected Visual Acuity of 1.6 Log Units | 6 months | • number and percentage of patients having Best Corrected Visual Acuity of 1.6 Log Units or better pre-operatively and 6 months after re-surgery in silicone oil filled eyes |
| 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 having Proliferative Vitreoretinopathy under silicone oil * Number and percentage of eyes having retinal breaks under silicone oil * Number and percentage of patients having Epimacular membranes under silicone oil * Number and percentage of patients having associated systemic comorbities- diabetes, hypertension, cardiac issues, dyslipidemia, chronic kidney disease |
| 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 | * Number and percentage of eyes with cataract progression post re-surgery in silicone oil filled eyes * Number and percentage of patients who underwent concurrent cataract surgery along with re-surgery in silicone oil filled eyes * Number and percentage of eyes with Epiretinal membrane post re-surgery in silicone oil filled eyes * Number and percentage of eyes with Silicone oil migration to Anterior chamber post re-surgery in silicone oil filled eyes * Number and percentage of patients with Corneal decompensation post re-surgery in silicone oil filled eyes * Number and percentage of patients with Retinal re-detachment post Silicone oil removal * Number and percentage of patients with Postoperative hypotony post Silicone oil removal |
| IOP change post Retinal Resurgery in silicone oil filled eyes | 6 months | •Change in mean IOP before and after re-surgery in silicone oil filled eyes |
Countries
India
Outcome results
None listed