Clinical trial NCT06583798: Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes
Official title: Anatomical And Visual Outcomes of Retinal Re-surgeries in Silicone Oil Filled Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Proliferative Vitreo-Retinopathy
Proliferative Diabetic Retinopathy
Keywords: Retinal Re-detachment
In silicone filled eyes
Under silicone oil
Proliferative Vitreoretinopathy
Lead sponsor: Ahalia Foundation Eye Hospital
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Best Corrected Visual Acuity as assessed by LogMAR (Logarithm Minimum Angle of Resolution) chart
timeFrame: 6 months after Resurgery; 1 month post Silicone oil removal in eyes undergoing silicone oil removal
measure: Number and Percentage of eyes with Retina Reattched after resurgery in Silicone oil filled eyes
timeFrame: •6 months post resurgery; •3 months post silicone oil removal in Patients who underwent silicone oil removal
Secondary outcomes:
measure: number and percentage of patients having Best Corrected Visual Acuity of 1.6 Log Units
timeFrame: 6 months
measure: Number and percentage of eyes/patients having various risk factors for retinal detachment after primary surgery in silicone oil filled eyes
timeFrame: 6 months
measure: Number and percentage of eyes/patients with adverse events intraoperative and post re-surgery in silicone oil filled eyes
timeFrame: 6 months post resurgery; 3 months post Silicone oil removal
measure: IOP change post Retinal Resurgery in silicone oil filled eyes
timeFrame: 6 months
Other outcomes:
Locations:
city: Palakkad
country: India
facility: Ahaliafoundation Eye Hospital
state: Kerala
Study officials:
affiliation: Ahalia Foundation Eye Hospital
name: Rajkumar Maheshwari, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ahalia Foundation Eye Hospital
name: C R Asla Jahan, DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Ahalia Foundation Eye Hospital
name: Saurav Mahajan, MS
role: PRINCIPAL_INVESTIGATOR
References: