Choroidal Neovascularization, Visual Field, Visual Acuity Clinical Trial
— CORFIOfficial title:
Evaluating the Link Between Active Neovascularization Found on OCT and Eye Fixation Quality Measured With Microperimetry in ARMD Patients Treated With antiVEGF
ARMD is the main cause of visual disability after 50 years old in France. Patients with
active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections
criteria are decrease of best corrected visual acuity or active neovascularization's signs
(mostly found on macular OCT but also on angiography when necessary).
The aim of this study is to evaluate the link between active neovascularization found on OCT
and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.
Quality of eye fixation and exudative signs presents or not present on OCT will be gathered
at each consultation over the two-years follow-up for each patient. The mean central retinal
sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will
also be gathered.
In case no link will be found, for instance bad fixation quality without exudative signs on
OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an
interest to improve reinjections criteria with a treatment more suitable to the patient.
| Status | Recruiting |
| Enrollment | 110 |
| Est. completion date | February 13, 2021 |
| Est. primary completion date | February 13, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - patients > 50 years old, - With neovascular ARMD - who need an induction treatment (de novo patients or patients who had their last intravitreal injection of antiVEGF more than 6 months ago) Exclusion Criteria: - Other maculopathies - Severe glaucoma with central visual field defect - Diabetic patients - Corneal, lens or vitreous opacities interfering in OCT analysis - Attention or comprehension deficit |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital | Limoges |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Limoges |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | fixation stability measured by microperimetry and exudative signs on OCT | quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up. The fixation stability is classified as follows: Stable if more than 75% of the fixation points are contained inside the circle of 2 degrees of diameter Relatively unstable if more than 75% of the fixation points are contained within the circle of 4 degrees of diameter and less than 75% contained within that of 2 degrees of diameter Unstable if less than 75% of the fixation points are contained within the circle of 4 degrees of diameter |
2 years | |
| Secondary | Bivariate Contour Ellipse Area (BCEA) value | BCEA will be gathered at each consultation over the two-years follow-up | 2 years | |
| Secondary | mean central retinal sensitivity | mean central retinal sensitivity will be gathered at each consultation over the two-years follow-up | 2 years | |
| Secondary | Best Corrected Visual Acuity (BCVA) | BCVA will be gathered at each consultation over the two-years follow-up | 2 years |