NCT06211907

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
3 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jul 2024Jun 2028

First Submitted

Initial submission to the registry

November 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

July 14, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

November 20, 2023

Last Update Submit

November 4, 2024

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (1)

  • Macular hole closure after single surgery

    Closure verified on OCT

    4 weeks

Secondary Outcomes (2)

  • Change in outcome of patient well-being

    4 weeks and 4 months

  • Change in visual acuity i ETDRS lines

    4 weeks and 4 months

Study Arms (2)

Gas tamponade

ACTIVE COMPARATOR

Intravitreal gas tamponade

Device: Postoperative intraocular tamponade

Air tamponade

EXPERIMENTAL

Intravitreal Air tamponade

Device: Postoperative intraocular tamponade

Interventions

Postoperative intraocular tamponadeDEVICE

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

Air tamponadeGas tamponade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Ophthalmology, University of Thessaly

Thessaly, Thessaly, 38221, Greece

NOT YET RECRUITING

Stavanger University Hospital

Stavanger, Rogaland, 4026, Norway

RECRUITING

University Hospital of Northern Norway

Tromsø, Troms, 9019, Norway

RECRUITING

St. Olavs University Hospital

Trondheim, Tronderlag, 7030, Norway

RECRUITING

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

Clinical Universitary Hospital of Santiago

Santiago de Compostela, La Coruna, 15706, Spain

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-inferiority Trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

January 18, 2024

Study Start

July 14, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

November 6, 2024

Record last verified: 2024-11

Locations

NO(5)ES(1)GR(1)