Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes

NCT06583798 | Completed

• 3 other identifiers: 202201.U1111-1312-4448TP232602676
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Detachment; Proliferative Vitreo-Retinopathy; Proliferative Diabetic Retinopathy

Keywords

Retinal Re-detachment; In silicone filled eyes; Under silicone oil; Proliferative Vitreoretinopathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• number and percentage of patients having Best Corrected Visual Acuity of 1.6 Log Units

  6 months

• 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/patients with adverse events intraoperative and post re-surgery in silicone oil filled eyes

  6 months post resurgery; 3 months post Silicone oil removal

• IOP change post Retinal Resurgery in silicone oil filled eyes

  6 months

Interventions

Resurgery In Silicone Oil Filled Eyes PROCEDURE

* 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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahalia Foundation Eye Hospital: lead

Study Sites (1)

Ahaliafoundation Eye Hospital

Palakkad, Kerala, 678557, India

Location

MeSH Terms

Conditions

Retinal Detachment; Vitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Rajkumar Maheshwari, MS

  Ahalia Foundation Eye Hospital

  PRINCIPAL INVESTIGATOR

• C R Asla Jahan, DNB

  Ahalia Foundation Eye Hospital

  PRINCIPAL INVESTIGATOR

• Saurav Mahajan, MS

  Ahalia Foundation Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor Adjunct

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: September 4, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)