Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy

Retinal Detachment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902795
• Other study ID #: 0004
• Status: Completed
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: April 2019
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Vitrectomy

Intervention

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.
• 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
Poland	General Department of Ophthalmology in Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

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 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.	1 to 6 months
Primary	M-charts	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.	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
Primary	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.	1 to 6 months