Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy

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

Sponsors

Lead Sponsor: Medical University of Lublin

Source Medical University of Lublin
Brief 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.

Detailed 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.

Overall Status Completed
Start Date March 2016
Completion Date October 2017
Primary Completion Date October 2017
Study Type Observational
Primary Outcome
Measure Time Frame
The best-corrected visual acuity (BCVA) 1 to 6 months
Amsler test 1 to 6 months
M-charts 1 to 6 months
Central retinal thickness 1 to 6 months
Microperimetry 1 to 6 months
Enrollment 62
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Microperimetry

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

Arm Group Label: Group of 62 eyes

Intervention Type: Diagnostic Test

Intervention Name: M-charts

Description: 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.

Arm Group Label: Group of 62 eyes

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Location
Facility: General Department of Ophthalmology in Lublin
Location Countries

Poland

Verification Date

April 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Group of 62 eyes

Description: Group of 62 eyes with rhegmatogenous retinal detachment who underwent successful vitrectomy with SF6 tamponade

Patient Data Yes
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov