Outcomes of Retinal Re-suregries in Silicone Oil Filled Eyes
NCT Number: NCT06583798
Acronym: ReSxinSO
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Retinal Detachment|Proliferative Vitreo-Retinopathy|Proliferative Diabetic Retinopathy
Sponsor: Ahalia Foundation Eye Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-06-30

Summary:
Anatomical and Visual outcomes of retinal re-surgeries done in silicone oil filled eyes

Primary Outcome Measures: Change in Best Corrected Visual Acuity as assessed by LogMAR (Logarithm Minimum Angle of Resolution) chart, * 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, 6 months after Resurgery; 1 month post Silicone oil removal in eyes undergoing silicone oil removal|Number and Percentage of eyes with Retina Reattched after resurgery in Silicone oil filled eyes, * 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, •6 months post resurgery; •3 months post silicone oil removal in Patients who underwent silicone oil removal
Secondary Outcome Measures: number and percentage of patients having Best Corrected Visual Acuity of 1.6 Log Units, • 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, 6 months|Number and percentage of eyes/patients having various risk factors for retinal detachment after primary surgery in silicone oil filled eyes, * 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, 6 months|Number and percentage of eyes/patients with adverse events intraoperative and post re-surgery in silicone oil filled eyes, * 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, 6 months post resurgery; 3 months post Silicone oil removal|IOP change post Retinal Resurgery in silicone oil filled eyes, •Change in mean IOP before and after re-surgery in silicone oil filled eyes, 6 months