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Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902795
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Retinal Detachment Vitrectomy Diagnostic Test: Microperimetry Diagnostic Test: M-charts

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.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study included 62 eyes that underwent successful vitrectomy with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902795


Locations
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Poland
General Department of Ophthalmology in Lublin
Lublin, Poland, 20-001
Sponsors and Collaborators
Medical University of Lublin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03902795    
Other Study ID Numbers: 0004
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be available in brief.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Lublin:
Rhegmatogenous retinal detachment
Vitrectomy
Metamorphopsia
M-charts
Microperimetry
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases