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

Completed

• Conditions: M-charts; Macular Holes; Microperymetry; Vitrectomy
• Interventions: Diagnostic Test: Microperymetry; Diagnostic Test: M-charts

• Registration Number: NCT03701542
• Lead Sponsor: Medical University of Lublin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-10
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Last Update Submitted: 2018-10-08
• Study First Posted: 2018-10-10
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

The diagnosed full thickness macular hole and psuedophakia.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group of 22 patients	Microperymetry	Group of 22 patients who underwent vitrectomy due to macular hole
Group of 22 patients	M-charts	Group of 22 patients who underwent vitrectomy due to macular hole

Primary Outcome Measures

Name	Time	Method
The best-corrected visual acuity (BCVA)	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
Amsler test	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.
Central retinal thickness	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 Outcome Measures

Name	Time	Method
Retinal sensitivity	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.