Small Macular Holes Treated With Air

NCT ID: NCT06211907

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-14

Study Completion Date

2028-06-30

Brief Summary

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

Detailed Description

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Conditions

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Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gas tamponade

Intravitreal gas tamponade

Group Type ACTIVE_COMPARATOR

Postoperative intraocular tamponade

Intervention Type DEVICE

Flushing the eye cavity with a tamponade at the end of surgery

Air tamponade

Intravitreal Air tamponade

Group Type EXPERIMENTAL

Postoperative intraocular tamponade

Intervention Type DEVICE

Flushing the eye cavity with a tamponade at the end of surgery

Interventions

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Postoperative intraocular tamponade

Flushing the eye cavity with a tamponade at the end of surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital, Trondheim, Norway

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital, Oslo, Norway

UNKNOWN

Sponsor Role collaborator

University Hospital of Northern Norway, Tromsø, Norway

UNKNOWN

Sponsor Role collaborator

University of Stavanger

OTHER

Sponsor Role collaborator

Royal Liverpool University Hospital

OTHER_GOV

Sponsor Role collaborator

Bangor University, Qwynedd, UK

UNKNOWN

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

University Hospital Complex of Santiago de Compostela, Galicia, Spain

UNKNOWN

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Ophthalmology, University of Thessaly

Thessaly, Thessaly, Greece

Site Status NOT_YET_RECRUITING

Stavanger University Hospital

Stavanger, Rogaland, Norway

Site Status RECRUITING

University Hospital of Northern Norway

Tromsø, Troms, Norway

Site Status RECRUITING

St. Olavs University Hospital

Trondheim, Tronderlag, Norway

Site Status RECRUITING

Haukeland University Hospital

Bergen, Vestland, Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Clinical Universitary Hospital of Santiago

Santiago de Compostela, La Coruna, Spain

Site Status RECRUITING

Countries

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Greece Norway Spain

Facility Contacts

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Nikolaos Dervenis, Research associate

Role: primary

+306936615677

Sofia Androudi, Associate Professor

Role: backup

+306932654030

Vegard A Forsaa, PhD

Role: primary

+4748152212

Birger Lindtjorn, PhD

Role: backup

+4795826869

Kristian A Fossen, MD

Role: primary

+4747029181

Nina K Angelsen, MD

Role: backup

Dordi K Austeng, PhD

Role: primary

+4747352135

Terje G Fagerholt, MD

Role: backup

+4793223924

Joergen G Krohn, PhD

Role: primary

+4790622668

Pal Varhaug, MD

Role: backup

+4790642717

Marta Haugstad, MD

Role: primary

+4795773548

Ingar Stene-Johansen, MD

Role: backup

+4794037570

Maria Jose Teijeiro

Role: primary

+34981951757

Joaquin Marticorena, PhD

Role: backup

+34981951757

Other Identifiers

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REK 580226

Identifier Type: -

Identifier Source: org_study_id

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