OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Silicone oil is commonly used as a temporary intraocular tamponade to support the retina during vitreoretinal surgery for complex retinal detachment and other severe retinal conditions. Although removing silicone oil typically leads to visual improvement, the degree of visual recovery varies widely among patients. Optical coherence tomography (OCT) is a non-invasive imaging technique that provides detailed cross-sectional views of the macula, the central portion of the retina responsible for detailed vision.
The primary aim of this observational study is to evaluate the relationship between specific macular OCT biomarkers (such as central macular thickness, ellipsoid zone integrity, and macular edema) measured before silicone oil removal and visual outcomes after surgery. Identifying these structural features may help ophthalmologists better predict visual recovery and counsel patients prior to surgery.
Participants will undergo a standard comprehensive ophthalmic examination, best-corrected visual acuity (BCVA) testing, and a macular OCT scan prior to their scheduled silicone oil removal. Visual acuity will then be reassessed during a standard postoperative follow-up visit at least 1 month after surgery. Participation is observational and does not alter routine surgical or medical management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Scheduled for silicone oil removal after previous vitreoretinal surgery.
Adequate macular optical coherence tomography (OCT) image quality before silicone oil removal.
Ability and willingness to attend postoperative follow-up.
Disqualifiers
Active retinal pathology or any intraocular condition requiring additional vitreoretinal surgery at the time of silicone oil removal.
Significant media opacity preventing reliable best-corrected visual acuity (BCVA) or OCT assessment.
Pre-existing macular disease unrelated to the original retinal pathology that is expected to independently affect visual acuity.
Advanced glaucoma or optic neuropathy likely to be a major independent cause of visual loss.
Trial population
Adult patients aged 18 years or older scheduled for planned silicone oil removal following previous vitreoretinal surgery, recruited from the Vitreoretinal Unit, Department of Ophthalmology, Assiut University Hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Patients Undergoing Silicone Oil Removal
Trial outcomes
Primary outcomes
1
Change in Best-Corrected Visual Acuity (BCVA)
Best-corrected visual acuity (BCVA) is measured using standard ophthalmic charts and converted to logarithm of the minimum angle of resolution (logMAR) units for quantitative analysis. Lower logMAR values indicate better visual acuity. The change is calculated as the postoperative value minus the preoperative baseline value.
Time frame
Baseline and 1 month after silicone oil removalLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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