Retinal Microvasculature Before and After Silicone Oil by OCTA

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04928196
Collaborator
(none)
30
1
13.6
2.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Microperimtery and optical coherence tomography angiography OCTA

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography
Actual Study Start Date :
Jul 12, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Macular and optic nerve head vascular density [one year]

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

  2. Retinal sensitivity by microperimetry [one year]

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

Secondary Outcome Measures

  1. Retinal vascular density and best corrected visual acuity [one year]

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

  2. Optic nerve head vascular density and best corrected visual acuity [one year]

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

  3. Retinal sensitivity and best corrected visual acuity [one year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University teaching hospital Cairo Egypt 11562

Sponsors and Collaborators

  • Kasr El Aini Hospital

Investigators

  • Principal Investigator: Hebatalla S. Makled, MD, Kasr El Aini Hospital
  • Principal Investigator: Ghada A. Nassar, MD, Kasr El Aini Hospital
  • Principal Investigator: Maha M. Youssef, MD, Kasr El Aini Hospital
  • Principal Investigator: Lameece M. Hassan, MD, Kasr El Aini Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebatalla Makled, Ophthalmology lecturer, Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT04928196
Other Study ID Numbers:
  • 6-1-2021-1
First Posted:
Jun 16, 2021
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hebatalla Makled, Ophthalmology lecturer, Kasr El Aini Hospital

Study Results

No Results Posted as of Sep 1, 2021