Comparison of Quantitative Metamorphopsia- Measurements in Patients With mCNV

NCT04112524 | Completed

• 1 other identifier: Metamorphopsia Study
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The myopic CNV (mCNV) is a blood vessel neoplasm starting from the choroid, based on pathological myopia (severe myopia). Choroidal neovascularization secondary to pathological myopia is the most common cause of severe visual impairment in myopic patients younger than 50 years old. Because untreated small fibrovascular membranes cause rapid damage to the photoreceptors, timely treatment is required in view of poor spontaneous prognosis1. Metamorphopsia is the first functional impairment which occurs in mCNV - visual acuity loss and scotoma follow later. There is a need for better and quicker quantifying of the metamorphopsia in mCNV patients. The aim of this study is to detect metamorphopsia and verify correlations of different indexes with disease activity or not, measured in Optical Cohorence Tomography (OCT), best corrected visual acuity (BCVA), Vision related quality of life questionnaire (NEI-VFY-25) and quantify severity of metamophopsia.

Conditions

Metamorphopsia

Outcome Measures

Primary Outcomes (1)

• Metamorphopsia index change from baseline (no mCNV activity) to month 6 and 12 and all visits in between (disease activity dependent) for the following two devices - AMD-A Metamorphopsia Detector® (app4eyes - TEST) - Alleye® Test

  Metamorphopsia index change (disease activity)

  1 year

Secondary Outcomes (3)

• CRT (central retinal thickness) measured in OCT

  1 year

• -outer retina disruption score within central 1mm (measured in OCT) -maximum CNV thickness within central 1mm (measured in OCT) -area of pigment epithelium atrophy within central 1mm measured in autofluorescence imaging

  1 year

• NEI VFQ-25 questionnaire -BCVA (best corrected visual acuity)

  1 year

Study Arms (1)

Patients from routine treatment

all 30 patients from Routine Treatment, only observational

Device: App

Interventions

App DEVICE

* Alleye® Test Alleye® Test is a mobile medical software application indicated for the detection and characterization of metamorphopsia. For the mean Alleye score (±standard deviation (SD) deviations of dots from an ideal line are calculated for each eye. * AMD-A Metamorphopsia Detector® Is based on the Amsler grid. The software uses the concept of a negative image: a distorted image can be straightened by moving the mouse. Degree and dimension of distorted lines or scotoma are transformed into indices.

Patients from routine treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients in retina- routine control

You may qualify if:

• diagnosis of mCNV involving the juxtafoveal or/and foveal region
• BCVA \>0.1 (20/200, Snellen)
• ability to follow the study procedures
• given written consent to participation
• \>18 years

You may not qualify if:

• history of vitreoretinal surgery (including membrane peeling and retinal detachment surgery) to the study eye
• presence of macula foramen or epiretinal membrane with significant distortion of retinal architecture
• history of any side effects to Tropicamide eye drops

Sponsors & Collaborators

• PD Dr. med. Katja Hatz: lead

Study Sites (1)

Vista Klinik

Binningen, Basel-Landschaft, 4102, Switzerland

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinical research and medical retina, Vista Klinik

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: October 8, 2019
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

CH (1)