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

September 23, 2024 updated by: Dr. Saurav Mahajan, Ahalia Foundation Eye Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Palakkad, Kerala, India, 678557
        • Ahaliafoundation Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
•6 months post resurgery; •3 months post silicone oil removal in Patients who underwent silicone oil removal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
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
6 months post resurgery; 3 months post Silicone oil removal
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahalia Foundation Eye Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saurav Mahajan, MS, Ahalia Foundation Eye Hospital
  • Principal Investigator: Rajkumar Maheshwari, MS, Ahalia Foundation Eye Hospital
  • Principal Investigator: C R Asla Jahan, DNB, Ahalia Foundation Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202201.
  • U1111-1312-4448 (Other Identifier: WHO UTN)
  • TP232602676 (Other Identifier: NBEMS THESIS CONDUCT SECTION)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings