A study looking at the accuracy of using optical coherence tomography angiography at diagnosing an eye condition called neovascular age-related macular degeneration to see if it is just as good as fluorescein angiography

Not Applicable

Completed

• Conditions: eovascular age-related macular degeneration (nAMD); Eye Diseases; Degeneration of macula and posterior pole

• Registration Number: ISRCTN18313457
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

2024 Protocol article in https://doi.org/10.1136/bmjopen-2022-070857 (added 03/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-11
• Study Completion: 2023-10-31
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1067

Inclusion Criteria

1. Patients presenting to secondary/specialist care centres with suspicion of nAMD in the first or second eye
2. Can provide informed consent
3. Have the ability to perform study-specific procedures

Exclusion Criteria

1. Significant media opacities (cataract, vitreous opacities) that would not allow good quality fundus imaging
2. Diabetic retinopathy of severity worse than mild non-proliferative stage and with any degree of diabetic maculopathy
3. Other causes of choroidal neovascularisation (myopic, angioid streaks, inflammatory, retinal dystrophies, secondary to central serous chorioretinopathy, idiopathic)
4. Inability to undergo dye-based imaging (FA or ICGA) due to history of allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of the index tests, OCTA combined with OCT and FA combined with OCT, for the detection of nAMD in participants with a positive or suspicious OCT at baseline. Sensitivity and specificity are defined respectively as the proportion of participants with nAMD that are correctly identified by the index tests as cases and the proportion of participants without nAMD that are correctly identified by the index tests as non-cases. The index tests are interpreted by clinicians (retinal experts)