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Not yet recruitingNCT07865468Updated Oct 8, 2026

OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal

An observational study in Retinal Detachment, Macular Edema and Silicone Oil Tamponade, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Assiut University · Observational

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Retinal Detachment
  • Macular Edema
  • Silicone Oil Tamponade
  • Epiretinal Membrane

Keywords

  • Silicone oil removal
  • Optical coherence tomography
  • Macular biomarkers
  • Ellipsoid zone integrity
  • Central macular thickness
  • Best-corrected visual acuity
  • Vitreoretinal surgery
  • Cystoid macular edema
03

In context

Retinal Detachment

207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.

This study's planned enrollment of 30 is below the median of 64 across 60 observational studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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 removal

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07865468
Lead sponsor
Assiut University
Responsible party
Mohamed Sayed Mahmoud Abdelhafiz (Resident, Assiut University) — Principal investigator
First posted
Oct 8, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 8, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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