Small Macular Holes Treated With Air

Not Applicable

Recruiting

• Conditions: Macular Holes
• Interventions: Device: Postoperative intraocular tamponade

• Registration Number: NCT06211907
• Lead Sponsor: Helse Stavanger HF

Brief Summary

Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-18
• Study Start: 2024-07-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Primary MH ≤250 μm
• MH duration ≤12 months
• No previous vitreoretinal surgery in study eye
• Ability to sign informed consent
• Signed informed consent
• Age ˃18 years

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Exclusion Criteria

• Previous vitreoretinal surgery in study eye
• Secondary MH caused by other conditions than vitreomacular traction
• Myopic MH, i.e., excessive myopia (more than -6 dioptres)
• Traumatic MH
• MH secondary to retinal detachment or other retinal diseases
• Previously participation in this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air tamponade	Postoperative intraocular tamponade	Intravitreal Air tamponade
Gas tamponade	Postoperative intraocular tamponade	Intravitreal gas tamponade

Primary Outcome Measures

Name	Time	Method
Macular hole closure after single surgery	4 weeks	Closure verified on OCT

Secondary Outcome Measures

Name	Time	Method
Change in outcome of patient well-being	4 weeks and 4 months	Questionnaire
Change in visual acuity i ETDRS lines	4 weeks and 4 months	Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome

Trial Locations

Locations (7)

University Hospital of Northern Norway; 🇳🇴 Tromsø, Troms, Norway

St. Olavs University Hospital; 🇳🇴 Trondheim, Tronderlag, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Vestland, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway

Clinical Universitary Hospital of Santiago; 🇪🇸 Santiago De Compostela, La Coruna, Spain

Department of Ophthalmology, University of Thessaly; 🇬🇷 Thessaly, Greece

Stavanger University Hospital; 🇳🇴 Stavanger, Rogaland, Norway