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Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade

NCT05223205 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-13

No results posted yet for this study

Summary

State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6. Air and SF6 have previously shown similar closure rates, although there was a trend towards lower closure rates in large diameter IMH (Idiopathic Macular Holes) using air. IMH with diameters \< 600 μm are currently believed to have similar closure rates with air and SF6. The investigators want to assess possible effects of the used tamponade (air or SF6) on closure rates and perfusion parameters represented by OCTA (Optical coherence tomography angiography). IMH eyes with a minimum diameter \> 600 μm will be excluded. Two idiopathic macular hole patient groups will therefore be formed: The first group (group 1) will receive air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% SF6 (and 90% air) after vitrectomy and membrane peeling. After recruitment, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCT (Optical coherence tomography) and OCTA.

Note: The trial was registered retrospectively on Clinicaltrials.gov after start of recruitment.

Conditions

  • Macular Holes
  • Optical Coherence Tomography

Interventions

PROCEDURE

Air

Test if air is sufficient for macular hole closure.

PROCEDURE

10% SF6 and 90% air

Test if 10% SF6 and 90% air is sufficient for macular hole closure.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2023-02-06
Completion
2023-06-06

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223205 on ClinicalTrials.gov