Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy
|ClinicalTrials.gov Identifier: NCT03902795|
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment|
|Retinal Detachment Vitrectomy||Diagnostic Test: Microperimetry Diagnostic Test: M-charts|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||62 participants|
|Official Title:||Functional and Morphological Results of macula-on and Macula-off Rhegmatogenous Retinal Detachment Treated With Pars Plana Vitrectomy and Sulfur Hexafluoride Gas Tamponade|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Group of 62 eyes
Group of 62 eyes with rhegmatogenous retinal detachment who underwent successful vitrectomy with SF6 tamponade
Diagnostic Test: Microperimetry
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 Test: 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902795
|General Department of Ophthalmology in Lublin|
|Lublin, Poland, 20-001|