Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583798
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-24
Brief Title:
Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anatomical And Visual Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReSxinSO
Brief Summary:
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 AcuityBCVA 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 biomicroscope90 Diopter lens examination and indirect ophthalmoscopy with 20 Diopter lens of the fundus will be done
Spectral domain OCTOptical 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 BCVABest 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 OCTOptical 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
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 AcuityBCVA 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 biomicroscope90 Diopter lens examination and indirect ophthalmoscopy with 20 Diopter lens of the fundus will be done
Spectral domain OCTOptical 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 BCVABest 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 OCTOptical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None