NCT06583798

Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes

Anatomical And Visual Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Ahalia Foundation Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Detachment
• Proliferative Vitreo-Retinopathy
• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
PROCEDURE	Resurgery 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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2024-09-04
• Last updated: 2024-09-25

Locations

1 site across 1 country: India