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Completed

NCT Number: NCT06583798

Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahaliafoundation Eye Hospital

Palakkad, Kerala, 678557, India

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Best Corrected Visual Acuity as assessed by LogMAR (Logarithm Minimum Angle of Resolution) chart

    Time frame: 6 months after Resurgery; 1 month post Silicone oil removal in eyes undergoing silicone oil removal

    • 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
  2. Number and Percentage of eyes with Retina Reattched after resurgery in Silicone oil filled eyes

    Time frame: •6 months post resurgery; •3 months post silicone oil removal in Patients who underwent silicone oil removal

    • 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

Secondary outcomes

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

    Time frame: 6 months

    • 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
  2. Number and percentage of eyes/patients having various risk factors for retinal detachment after primary surgery in silicone oil filled eyes

    Time frame: 6 months

    • 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
  3. Number and percentage of eyes/patients with adverse events intraoperative and post re-surgery in silicone oil filled eyes

    Time frame: 6 months post resurgery; 3 months post Silicone oil removal

    • 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
  4. IOP change post Retinal Resurgery in silicone oil filled eyes

    Time frame: 6 months

    •Change in mean IOP before and after re-surgery in silicone oil filled eyes

Sponsors and collaborators

Lead sponsor

Ahalia Foundation Eye Hospital

Other

Registry information

Official study title

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

Acronym: ReSxinSO

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 4, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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