Retinal DetachmentReSxinSONCT06583798
Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes
An observational study of Retinal Detachment and Proliferative Vitreo-Retinopathy, run by Ahalia Foundation Eye Hospital at 1 site in India.
Trial summary
Anatomical and Visual outcomes of retinal re-surgeries done in silicone oil filled eyes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Retinal Detachment, Proliferative Vitreo-Retinopathy, Proliferative Diabetic Retinopathy
- What is being tested?
- Resurgery In Silicone Oil Filled Eyes
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Being tested
- Resurgery In Silicone Oil Filled Eyes
- Keywords
- Retinal Re-detachment, In silicone filled eyes, Under silicone oil, Proliferative Vitreoretinopathy
- Medical subject headings
- Retinal Detachment, Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resurgery In Silicone Oil Filled EyesProcedure or surgery
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: •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
- 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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months post resurgery; 3 months post Silicone oil removal
IOP change post Retinal Resurgery in silicone oil filled eyes
•Change in mean IOP before and after re-surgery in silicone oil filled eyes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahalia Foundation Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Saurav Mahajan, Ahalia Foundation Eye Hospital
- Investigators
- Rajkumar Maheshwari, MS, Principal investigator, Ahalia Foundation Eye HospitalC R Asla Jahan, DNB, Principal investigator, Ahalia Foundation Eye HospitalSaurav Mahajan, MS, Principal investigator, Ahalia Foundation Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583798
- Sponsor's protocol ID
- 202201.
- Other IDs
- U1111-1312-4448, TP232602676
- Acronym
- ReSxinSO
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical And Visual Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes
- ClinicalTrials.gov ID
- NCT06583798
- Acronym / sponsor ID
- ReSxinSO / 202201.
- Keywords
- Retinal Re-detachment, In silicone filled eyes, Under silicone oil, Proliferative Vitreoretinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ahalia Foundation Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anatomical and Visual outcomes of retinal re-surgeries done in silicone oil filled eyes
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resurgery 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. | Procedure or surgery | – |
Primary outcome
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
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
4 secondary outcomes
number and percentage of patients having Best Corrected Visual Acuity of 1.6 Log Units
Time frame: 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/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
IOP change post Retinal Resurgery in silicone oil filled eyes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment and Proliferative Vitreo-Retinopathy, run by Ahalia Foundation Eye Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.