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M Charts Versus Amsler Test in Evaluating Metamorphopsia in nAMD

NCT05324150 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2023-11-02

No results posted yet for this study

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.

Conditions

  • Macular Degeneration, Wet
  • Metamorphopsia

Sponsors & Collaborators

  • Ospedale Santa Croce-Carle Cuneo

    lead OTHER

Principal Investigators

  • Silvia Violante, MD · OSCroceCarle, +39 0171 641571

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2023-06-30
Completion
2023-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05324150 on ClinicalTrials.gov