ClinicalTrials.gg
RecruitingNCT06211907Updated Nov 6, 2024

Small Macular Holes Treated With Air

An interventional study of Postoperative intraocular tamponade in Macular Holes, sponsored by Helse Stavanger HF. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.

Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Macular Holes

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03

In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's planned enrollment of 132 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Helse Stavanger HF is the lead sponsor of 97 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary MH ≤250 μm
  • MH duration ≤12 months
  • No previous vitreoretinal surgery in study eye
  • Ability to sign
  • Signed informed consent
  • Age ˃18 years

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Active comparator
    Gas tamponade

    Intravitreal gas tamponade

    Device: Postoperative intraocular tamponade

  • Experimental
    Air tamponade

    Intravitreal Air tamponade

    Device: Postoperative intraocular tamponade

Interventions

  • DevicePostoperative intraocular tamponade

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

06

What researchers measure

Primary outcomes

  1. Macular hole closure after single surgery

    Closure verified on OCT

    Time frame: 4 weeks

Secondary outcomes

  1. Change in outcome of patient well-being

    Questionnaire

    Time frame: 4 weeks and 4 months

  2. Change in visual acuity i ETDRS lines

    Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome

    Time frame: 4 weeks and 4 months

07

Study locations

6 of 7 sites recruiting
  • Department of Ophthalmology, University of Thessaly
    Thessaly, 38221, Greece
    Not yet recruiting
    • Nikolaos Dervenis, Research associate · Contactnikosdervenis@gmail.com · +306936615677
    • Sofia Androudi, Associate Professor · Contactandroudi@otenet.gr · +306932654030
    • Nikolaos Dervenis, Research associate · Principal investigator
    • Sofia Androudi, Associate Professor · Sub investigator
  • Stavanger University Hospital
    Stavanger, Rogaland 4026, Norway
    Recruiting
    • Vegard A Forsaa, PhD · Contactforsaa@gmail.com · +4748152212
    • Birger Lindtjorn, PhD · Contactbirgerl@gmail.com · +4795826869
    • Vegard A Forsaa, PhD · Principal investigator
    • Birger Lindtjorn · Sub investigator
  • 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
    • Joergen G Krohn, PhD · Contactjoerkroh@online.no · +4790622668
    • Pal Varhaug, MD · Contactpalvarhaug@helse-bergen.no · +4790642717
    • Joergen G Krohn, PhD · Principal investigator
    • Pal Varhaug, MD · Sub investigator
  • Oslo University Hospital
    Oslo, 0424, Norway
    Recruiting
    • Marta Haugstad, MD · ContactUXARGS@ous-hf.no · +4795773548
    • Ingar Stene-Johansen, MD · ContactUXINTE@ous-hf.no · +4794037570
    • Marta Haugstad, MD · Principal investigator
    • Ingar Stene-Johansen, MD · Sub investigator
  • Clinical Universitary Hospital of Santiago
    Santiago De Compostela, La Coruna 15706, Spain
    Recruiting
    • Maria Jose Teijeiro · Contactmjblantei@gmail.com · +34981951757
    • Joaquin Marticorena, PhD · Contactjmarticorena@gmail.com · +34981951757
    • Maria Jose Teijeiro · Principal investigator
    • Joaquin Marticorena · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jun 2028, 47 months after the start.

Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 47 months is above that.

Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2023
First posted
Jan 18, 2024
StartActual
Jul 14, 2024
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Nov 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06211907
Lead sponsor
Helse Stavanger HF
Collaborators
Haukeland University Hospital, St. Olavs Hospital, Trondheim, Norway, Oslo University Hospital, Oslo, Norway, University Hospital of Northern Norway, Tromsø, Norway, University of Stavanger, Royal Liverpool University Hospital, Bangor University, Qwynedd, UK, McGill University, University Hospital Complex of Santiago de Compostela, Galicia, Spain
Responsible party
Sponsor
First posted
Jan 18, 2024
Start date
Jul 14, 2024
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 6, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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