CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT05324150
NCT05324150N/ACompleted

M Charts Versus Amsler Test in Evaluating Metamorphopsia in Neovascular AMD Patients Treated With Anti-VEGF

Ospedale Santa Croce-Carle Cuneo·observational·Posted Apr 12, 2022·Updated Nov 2, 2023

In Brief

An observational study for Macular Degeneration, Wet and Metamorphopsia. Completed, enrolled 57 participants across 1 site.

Detailed Summary

Age-related macular degeneration (AMD) is a complex eye disorder and the most common macular disease affecting millions of aged people in the developed countries, with an estimation that the number of AMD patients will be increased to 196 million in 2020, 288 million in 2040. Vision loss, central scotomas and metamorphopsia are the hallmark signs in patients with macular diseases. Metamorphopsia can be defined as a deformation of seen rectilinear lines due to photoreceptor separation/location and it is a typical but not exclusive sign of retinal disease. The most effective method of treating wet AMD is currently the anti-vascular endothelial growth factor intravitreal injections (anti-VEGF). A further concern is the enormous costs and restriction of human resources that make periodic imaging unfeasible. Therefore, in patients with AMD treated by intravitreal anti-VEGF, monitoring with sensitive psychophysical tools could advance the time for diagnosis of CNV reactivation and enhance the outcome of treatment. For assessment of the visual function, visual acuity and Amsler grid have been the gold standard. The Amsler grid is a simple and noninvasive test effortlessly understood by the patient, consisting of evenly spaced vertical and horizontal lines outlining 400 square, it has been widely adopted as a subjective test for metamorphopsia. However, it also produces high false-negative rate. Moreover, the answer to this test is dichotomous: straight or crooked lines and does not allow for quantification thus, it is problematic to monitor the visual function along the course and to evaluate the effectiveness of treatment with anti-VEGF agents. The M-chart (Inami Co., Tokyo, Japan) is a diagnostic device developed by Matsumoto to quantify the grade of metamorphopsia in patients with various types of macular diseases. The usefulness of M-charts has been already demonstrated in different retinal diseases from macular pucker to BRVO. The aim of this study is to compare the traditional Amsler grid and the M-Charts in evaluating metamorphopsia in patients suffering from wet AMD before and after Anti VEGF injection; and to match it with OCT results.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 12, 2022
Enrollment StartMay 9, 2022
Primary CompletionJun 30, 2023
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.2 years ago