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Air Tamponade and Non-supine Positioning in Macular Hole Surgery.

NCT03572725 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-09-28

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized non-inferiority trial, where the macular hole closure rate with intraocular air tamponade is compared to the closure rate with gas tamponade.The patients are randomized to receive either air or gas (26% SF6) as intraocular tamponade, just prior to the intraocular flushing of the tamponade during the vitrectomy procedure. Postoperatively, the patients adhere to the nonsupine regimen for three days, and the tennis ball technique is used during sleep to enhance patients' positioning compliance.

Conditions

  • Macular Holes

Interventions

PROCEDURE

Gas tamponade

Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.

PROCEDURE

Air tamponade

Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • Trondheim University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Vegard Forsaa, PhD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2021-05-28
Completion
2021-05-28

Countries

  • Norway

Study Locations

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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 NCT03572725 on ClinicalTrials.gov