Small Macular Holes Treated With Air

Macular Holes Clinical Trial

Official title:

Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211907
• Other study ID #: REK 580226
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2023
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Device:
• Postoperative intraocular tamponade
Flushing the eye cavity with a tamponade at the end of surgery

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Helse Stavanger HF	Bangor University, Qwynedd, UK, Haukeland University Hospital, McGill University, Oslo University Hospital, Oslo, Norway, Royal Liverpool University Hospital, St. Olavs Hospital, Trondheim, Norway, University Hospital Complex of Santiago de Compostela, Galicia, Spain, University Hospital of Northern Norway, Tromsø, Norway, University of Stavanger

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole closure after single surgery	Closure verified on OCT	4 weeks
Secondary	Change in outcome of patient well-being	Questionnaire	4 weeks and 4 months
Secondary	Change in visual acuity i ETDRS lines	Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome	4 weeks and 4 months