Retinal Microvasculature Before and After Silicone Oil by OCTA
Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2021
CompletedFirst Posted
Study publicly available on registry
June 16, 2021
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedMarch 14, 2023
March 1, 2023
12 months
June 5, 2021
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
one year
Retinal sensitivity by microperimetry
Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal
one year
Secondary Outcomes (3)
Retinal vascular density and best corrected visual acuity
one year
Optic nerve head vascular density and best corrected visual acuity
one year
Retinal sensitivity and best corrected visual acuity
one year
Interventions
observational: Investigations are done to assess the retinal microvasculature and function before and after silicone oil removal
Eligibility Criteria
Prospective observational case series of patients before and after silicone oil removal
You may qualify if:
- eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cairo University teaching hospital
Cairo, 11562, Egypt
Related Publications (1)
Nassar GA, Makled HS, Youssef MM, Hassan LM. Functional and perfusion changes associated with silicone oil tamponade after macula-off rhegmatogenous retinal detachment surgery: an optical coherence tomography angiography/microperimetry study. Int Ophthalmol. 2024 Feb 22;44(1):107. doi: 10.1007/s10792-024-03037-5.
PMID: 38386180DERIVED
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmology lecturer
Study Record Dates
First Submitted
June 5, 2021
First Posted
June 16, 2021
Study Start
July 12, 2021
Primary Completion
June 30, 2022
Study Completion
October 15, 2022
Last Updated
March 14, 2023
Record last verified: 2023-03