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CompletedNCT04928196Updated Mar 14, 2023

Retinal Microvasculature Before and After Silicone Oil by OCTA

An observational study in Retinal Vascular, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Kasr El Aini Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Sex
All
01

Study summary

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

Read the detailed description

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

02

Conditions studied

  • Retinal Vascular

Keywords

  • retinal microvasculature
  • microperimtry
  • OCTA
  • Silicone oil
03

In context

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Prospective observational case series of patients before and after silicone oil removal

Inclusion criteria

  • 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Exclusion criteria

Exclusion Criteria:

  • Proliferative diabetic retinopathy, recurrent detachment or macular hole
  • Patients with chorioretinal degenerations involving the macula
  • Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma
  • Media opacity hindering proper imaging
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • OtherMicroperimtery and optical coherence tomography angiography OCTA

    observational: Investigations are done to assess the retinal microvasculature and function before and after silicone oil removal

06

What researchers measure

Primary outcomes

  1. Macular and optic nerve head vascular density

    Using OCTA to assess vascular density changes of the macula and optic nerve head before and after silicone oil removal

    Time frame: one year

  2. Retinal sensitivity by microperimetry

    Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal

    Time frame: one year

Secondary outcomes

  1. Retinal vascular density and best corrected visual acuity

    Correlate the change in the retinal vascular density with best corrected visual acuity

    Time frame: one year

  2. Optic nerve head vascular density and best corrected visual acuity

    Correlate the change in the optic nerve head vascular density with best corrected visual acuity

    Time frame: one year

  3. Retinal sensitivity and best corrected visual acuity

    Correlate the change in the retinal sensitivity with best corrected visual acuity

    Time frame: one year

07

Study locations

1 site
  • Cairo University teaching hospital
    Cairo, 11562, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04928196
Lead sponsor
Kasr El Aini Hospital
Responsible party
Hebatalla Makled (Ophthalmology lecturer, Kasr El Aini Hospital) — Principal investigator
First posted
Jun 16, 2021
Start date
Jul 12, 2021
Primary completion
Jun 30, 2022
Completion
Oct 15, 2022
Last update
Mar 14, 2023

Study contacts

Hebatalla S. Makled, MD
principal investigator · Kasr El Aini Hospital
Ghada A. Nassar, MD
principal investigator · Kasr El Aini Hospital
Maha M. Youssef, MD
principal investigator · Kasr El Aini Hospital
Lameece M. Hassan, MD
principal investigator · Kasr El Aini Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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