NCT03902795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

April 1, 2019

Last Update Submit

April 3, 2019

Conditions

Retinal DetachmentVitrectomy

Keywords

Rhegmatogenous retinal detachmentVitrectomyMetamorphopsiaM-chartsMicroperimetry

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Group of 62 eyes

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

Diagnostic Test: MicroperimetryDiagnostic Test: M-charts

Interventions

MicroperimetryDIAGNOSTIC_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.

Group of 62 eyes
M-chartsDIAGNOSTIC_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.

Group of 62 eyes

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Department of Ophthalmology in Lublin

Lublin, 20-001, Poland

Location

Related Publications (1)

  • Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Junemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexafluoride gas tamponade. BMC Ophthalmol. 2019 May 24;19(1):118. doi: 10.1186/s12886-019-1120-3.

    PMID: 31126280DERIVED

MeSH Terms

Conditions

Retinal DetachmentVision Disorders

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 4, 2019

Study Start

March 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

All data will be available in brief.

Locations

PL(1)