Retinal DetachmentNCT07865468
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
An observational study of Retinal Detachment and Macular Edema, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment, Macular Edema, Silicone Oil Tamponade
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Observational
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 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Inability to complete postoperative follow-up.
About this study
Official title: Relationship Between OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
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.
- Keywords
- Silicone oil removal, Optical coherence tomography, Macular biomarkers, Ellipsoid zone integrity, Central macular thickness, Best-corrected visual acuity, Vitreoretinal surgery, Cystoid macular edema
- Medical subject headings
- Retinal Detachment, Macular Edema, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Silicone Oil Removal | Adult patients aged 18 years or older scheduled for planned silicone oil removal following prior vitreoretinal surgery (one eye per patient). All participants undergo baseline clinical ophthalmic examination and macular optical coherence tomography (OCT) imaging prior to silicone oil removal. Postoperative visual outcome, assessed by best-corrected visual acuity (BCVA), is evaluated at a follow-up visit occurring at least 1 month after silicone oil removal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month after silicone oil removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Mahmoud Abdelhafiz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865468
- Sponsor's protocol ID
- OCT Biomarkers and SOR Outcome
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No