ClinicalTrials.Veeva

Menu

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

A

Ahalia Foundation Eye Hospital

Status

Completed

Conditions

Retinal Detachment
Proliferative Vitreo-Retinopathy
Proliferative Diabetic Retinopathy

Treatments

Procedure: Resurgery In Silicone Oil Filled Eyes

Study type

Observational

Funder types

Other

Identifiers

NCT06583798
202201.
TP232602676 (Other Identifier)
U1111-1312-4448 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

33 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems