Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes

NCT ID: NCT06583798

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-06-30

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.

Conditions

Retinal Detachment; Proliferative Vitreo-Retinopathy; Proliferative Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahalia Foundation Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Saurav Mahajan

Principal Investigator, Clinical Professor Adjunct

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajkumar Maheshwari, MS

Role: PRINCIPAL_INVESTIGATOR

Ahalia Foundation Eye Hospital

C R Asla Jahan, DNB

Role: PRINCIPAL_INVESTIGATOR

Ahalia Foundation Eye Hospital

Saurav Mahajan, MS

Role: PRINCIPAL_INVESTIGATOR

Ahalia Foundation Eye Hospital

Locations

Ahaliafoundation Eye Hospital

Palakkad, Kerala, India

Countries

India

Other Identifiers

U1111-1312-4448

Identifier Type: OTHER

Identifier Source: secondary_id

TP232602676

Identifier Type: OTHER

Identifier Source: secondary_id

202201.

Identifier Type: -

Identifier Source: org_study_id