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OpenTrials
Completed

NCT Number: NCT03701542

The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.

To examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (FTMH).

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The diagnosed full thickness macular hole and psuedophakia.

Exclusion criteria

macular pseudohole, non-full thickness macular hole, retinal detachment, other ocular comorbidities.

Treatment and study plan

Microperymetry

Diagnostic Test

Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.

M-charts

Diagnostic Test

The M-chart (Inami Co., Tokyo, Japan) is a diagnostic tool developed by Matsumoto to quantify the degree of metamorphopsia in patients with macular diseases.

Primary outcomes

  1. The best-corrected visual acuity (BCVA)

    Time frame: 1 to 6 months

    Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable

  2. Amsler test

    Time frame: 1 to 6 months

    The Amsler grid, consisting of evenly spaced horizontal and vertical lines, has been widely used since 1947 to test the metamorphopsia.

  3. Central retinal thickness

    Time frame: 1 to 6 months

    Quantitative thickness measurements derived from the "fast macular scan" algorithm report retinal thickness at several locations including the center point, central subfield, and 4 inner and 4 outer zones of the macula.

Secondary outcomes

  1. Retinal sensitivity

    Time frame: 1 to 6 months

    Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality. It is a psychophysical method which is rapid, safe and non-invasive.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2018
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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