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

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701542
• Other study ID #: 0003
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2018
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

The diagnosed full thickness macular hole and psuedophakia.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• M-charts
• Macular Holes
• Microperymetry
• Retinal Perforations
• Vitrectomy

Intervention

Diagnostic Test:
• Microperymetry
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The best-corrected visual acuity (BCVA)	Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable	1 to 6 months
Primary	Amsler test	The Amsler grid, consisting of evenly spaced horizontal and vertical lines, has been widely used since 1947 to test the metamorphopsia.	1 to 6 months
Primary	Central retinal thickness	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.	1 to 6 months
Secondary	Retinal sensitivity	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.	1 to 6 months