Outcomes of Retinal Re-suregries in Silicone Oil Filled Eyes

Completed

• Conditions: Retinal Detachment; Proliferative Vitreo-Retinopathy; Proliferative Diabetic Retinopathy

• Registration Number: NCT06583798
• Lead Sponsor: Ahalia Foundation Eye Hospital

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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-24
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ahaliafoundation Eye Hospital; 🇮🇳 Palakkad, Kerala, India