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CompletedNCT03701542Updated Oct 10, 2018

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

An observational study in Macular Holes, Microperymetry and Vitrectomy, sponsored by Medical University of Lublin. Completed. Per ClinicalTrials.gov, last updated 2018-10-10.

Sponsored by Medical University of Lublin · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
22
Sex
All
01

Study summary

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

02

Conditions studied

  • Macular Holes
  • Microperymetry
  • Vitrectomy
  • M-charts

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Keywords

  • macular hole
  • microperymetry
  • vitrectomy
  • m-charts
  • metamorphopsia
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In context

Retinal Perforations

156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.

This study's enrollment of 22 is below the median of 42 across 51 observational studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Medical University of Lublin is the lead sponsor of 60 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

22 patients

Inclusion criteria

The diagnosed full thickness macular hole and psuedophakia.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • Group of 22 patients

    Group of 22 patients who underwent vitrectomy due to macular hole

    Diagnostic Test: Microperymetry · Diagnostic Test: M-charts

Interventions

  • Diagnostic testMicroperymetry

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

  • Diagnostic testM-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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 to 6 months

  2. Amsler test

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

    Time frame: 1 to 6 months

  3. 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.

    Time frame: 1 to 6 months

Secondary outcomes

  1. 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.

    Time frame: 1 to 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 33029387 ↗
  • 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. PubMed 31198606 ↗

Individual participant data

Plan to share: Yes — All data will be available in brief.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03701542
Lead sponsor
Medical University of Lublin
Responsible party
Sponsor
First posted
Oct 10, 2018
Start date
Jan 1, 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Oct 10, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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