Skip to main content
OpenTrials
Completed

NCT Number: NCT03902795

Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Retinal Detachment Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders Vitrectomy

Sex eligibility

All sexes

Study type

Observational

Primary location

General Department of Ophthalmology in Lublin

Lublin, 20-001, Poland

About this study

Background:

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Methods:

The study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.

Who can participate

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

Inclusion criteria

  • The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.

Exclusion criteria

  • history of uveitis,
  • diabetic retinopathy,
  • previous vitreoretinal surgery,
  • glaucoma or eye trauma,
  • retinal detachment combined with macular hole or proliferative vitreoretinopathy

Treatment and study plan

Microperimetry

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 standard Amsler test performs with black lines on the white background. The Amsler grid has been used so far for the qualitative assessment of the metamorphopsia since 1947.

  3. M-charts

    Time frame: 1 to 6 months

    The M-charts consist of 19 dashed lines with increasing distance between points in the range of 0.2 ° to 2.0 ° viewing angle. Matsumoto developed M-charts for quantitative metamorphopsia evaluation in macula diseases in 1990. M-charts provide more information than Amsler chart in regard to the horizontal and vertical lines.

  4. 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.

  5. Microperimetry

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Functional and Morphological Results of macula-on and Macula-off Rhegmatogenous Retinal Detachment Treated With Pars Plana Vitrectomy and Sulfur Hexafluoride Gas Tamponade

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2019
Registry last updated
Apr 4, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.