RECRUITINGNA

Small Macular Holes Treated With Air

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

Sponsor

Helse Stavanger HF

Enrollment

132 participants

Sites

7 locations

Start Date

July 2024

Completion

June 2028

Macular HolesPostoperative intraocular tamponade

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

132

participants

Sites

locations

Duration

3.9 years

total trial span

Rate

pts/month needed

Jul 2024Month 23 of 47Jun 2028

49% of trial timeline elapsed24 months to primary endpoint

At 7 sites, each site needs to enroll approximately 0.4 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

Macular hole closure after single surgery

4 weeks

Closure verified on OCT

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

RECRUITINGNA

Small Macular Holes Treated With Air

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

Sponsor

Helse Stavanger HF

Enrollment

132 participants

Sites

7 locations

Start Date

July 2024

Completion

June 2028

Macular HolesPostoperative intraocular tamponade

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

132

participants

Sites

locations

Duration

3.9 years

total trial span

Rate

pts/month needed

Jul 2024Month 23 of 47Jun 2028

49% of trial timeline elapsed24 months to primary endpoint

At 7 sites, each site needs to enroll approximately 0.4 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Macular hole closure after single surgery

4 weeks

Closure verified on OCT

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Sex

all

Healthy Volunteers

View full criteria

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 Sites (7)

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Department of Ophthalmology, University of Thessaly

Thessaly, Thessaly, Greece

Stavanger University Hospital

Stavanger, Rogaland, Norway

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

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