ClinicalTrials.gg
Sign In
CompletedNCT06583798ReSxinSOUpdated Sep 25, 2024

Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes

An observational study in Retinal Detachment, Proliferative Vitreo-Retinopathy and Proliferative Diabetic Retinopathy, sponsored by Ahalia Foundation Eye Hospital. Completed at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by Ahalia Foundation Eye Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
33
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Retinal Detachment
  • Proliferative Vitreo-Retinopathy
  • Proliferative Diabetic Retinopathy

Keywords

  • Retinal Re-detachment
  • In silicone filled eyes
  • Under silicone oil
  • Proliferative Vitreoretinopathy
03

In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 58 observational studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Ahalia Foundation Eye Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
33 participants (actual)
Patient registry
No

Interventions

  • ProcedureResurgery 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.

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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

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

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

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

    Time frame: 6 months

07

Study locations

1 site
  • Ahaliafoundation Eye Hospital
    Palakkad, Kerala 678557, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Dec 2023, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2024
First posted
Sep 4, 2024
StartActual
Jan 1, 2023
Primary completionActual
Dec 31, 2023
CompletionActual
Jun 30, 2024
Last update
Sep 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06583798
Lead sponsor
Ahalia Foundation Eye Hospital
Responsible party
Dr. Saurav Mahajan (Principal Investigator, Clinical Professor Adjunct, Ahalia Foundation Eye Hospital) — Principal investigator
First posted
Sep 4, 2024
Start date
Jan 1, 2023
Primary completion
Dec 31, 2023
Completion
Jun 30, 2024
Last update
Sep 25, 2024

Study contacts

Rajkumar Maheshwari, MS
principal investigator · Ahalia Foundation Eye Hospital
C R Asla Jahan, DNB
principal investigator · Ahalia Foundation Eye Hospital
Saurav Mahajan, MS
principal investigator · Ahalia Foundation Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Retinal Detachment →

Other studies from this sponsor

Ahalia Foundation Eye Hospital

Start the discussion