Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes (ReSxinSO)

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

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

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy; Retinal Detachment; Proliferative Vitreo-Retinopathy
• Intervention / Treatment: Procedure: Resurgery 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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• India
  • Kerala
    • Palakkad, Kerala, India, 678557
      • Ahaliafoundation Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients (South Indian Population) who attended retina Out patient department in Ahalia Foundation Eye Hospital, Palakkad and had to undergo Resurgery for Retinal Redetachment in various retinal pathologies

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ahalia Foundation Eye Hospital
• Investigators: Principal Investigator: Saurav Mahajan, MS, Ahalia Foundation Eye Hospital; Principal Investigator: Rajkumar Maheshwari, MS, Ahalia Foundation Eye Hospital; Principal Investigator: C R Asla Jahan, DNB, Ahalia Foundation Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: August 24, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Proliferative Vitreoretinopathy; Retinal Re-detachment; In silicone filled eyes; Under silicone oil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Vitreoretinopathy, Proliferative
• Other Study ID Numbers: 202201.; U1111-1312-4448 (Other Identifier: WHO UTN); TP232602676 (Other Identifier: NBEMS THESIS CONDUCT SECTION)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No