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Completed

NCT Number: NCT04928196

Retinal Microvasculature Before and After Silicone Oil by OCTA

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

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Key information

Conditions

Retinal Vascular

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University teaching hospital

Cairo, 11562, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microperimtery and optical coherence tomography angiography OCTA

Other

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

Primary outcomes

  1. Macular and optic nerve head vascular density

    Time frame: 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

    Time frame: one year

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

Secondary outcomes

  1. Retinal vascular density and best corrected visual acuity

    Time frame: 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

    Time frame: 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

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2021
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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