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

NCT03701542 | Completed

• 1 other identifier: 0003
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Macular Holes; Microperymetry; Vitrectomy; M-charts

Keywords

macular hole; microperymetry; vitrectomy; m-charts; metamorphopsia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Retinal sensitivity

  1 to 6 months

Study Arms (1)

Group of 22 patients

Group of 22 patients who underwent vitrectomy due to macular hole

Diagnostic Test: Microperymetry; Diagnostic Test: M-charts

Interventions

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.

Group of 22 patients

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.

Group of 22 patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

22 patients

You may qualify if:

• The diagnosed full thickness macular hole and psuedophakia.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Lublin: lead

Related Publications (2)

• Wrzesinska D, Nowomiejska K, Nowakowska D, Toro MD, Bonfiglio V, Reibaldi M, Avitabile T, Rejdak R. Secondary Vitrectomy with Internal Limiting Membrane Plug due to Persistent Full-Thickness Macular Hole OCT-Angiography and Microperimetry Features: Case Series. J Ophthalmol. 2020 Sep 21;2020:2650873. doi: 10.1155/2020/2650873. eCollection 2020.

  PMID: 33029387 DERIVED

• Wrzesinska D, Nowomiejska K, Nowakowska D, Brzozowska A, Avitabile T, Reibaldi M, Rejdak R, Toro M. Vertical and Horizontal M-Charts and Microperimetry for Assessment of the Visual Function in Patients after Vitrectomy with ILM Peeling due to Stage 4 Macular Hole. J Ophthalmol. 2019 May 6;2019:4975973. doi: 10.1155/2019/4975973. eCollection 2019.

  PMID: 31198606 DERIVED

MeSH Terms

Conditions

Retinal Perforations; Vision Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share