Small Macular Holes Treated With Air

Helse Stavanger HF

Status: Enrolling

Conditions: Macular Holes

Treatments: Device: Postoperative intraocular tamponade

Study type: Interventional

Funder types: Other

Identifiers

NCT06211907

REK 580226

Details and patient eligibility

About

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

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Gas tamponade

Active Comparator group

Description:

Intravitreal gas tamponade

Treatment:

Device: Postoperative intraocular tamponade

Air tamponade

Experimental group

Description:

Intravitreal Air tamponade

Treatment:

Device: Postoperative intraocular tamponade