Small Macular Holes Treated With Air

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

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

Study Overview

• Status: Recruiting
• Conditions: Macular Holes
• Intervention / Treatment: Device: Postoperative intraocular tamponade

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaly, Greece, 38221
    • Not yet recruiting
    • Department of Ophthalmology, University of Thessaly
    • Contact: Nikolaos Dervenis, Research associate; Phone Number: +306936615677; Email: nikosdervenis@gmail.com
    • Contact: Sofia Androudi, Associate Professor; Phone Number: +306932654030; Email: androudi@otenet.gr
    • Principal Investigator: Nikolaos Dervenis, Research associate
    • Sub-Investigator: Sofia Androudi, Associate Professor
• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: Marta Haugstad, MD; Phone Number: +4795773548; Email: UXARGS@ous-hf.no
    • Contact: Ingar Stene-Johansen, MD; Phone Number: +4794037570; Email: UXINTE@ous-hf.no
    • Principal Investigator: Marta Haugstad, MD
    • Sub-Investigator: Ingar Stene-Johansen, MD
  • Rogaland
    • Stavanger, Rogaland, Norway, 4026
      • Recruiting
      • Stavanger University Hospital
      • Contact: Vegard A Forsaa, PhD; Phone Number: +4748152212; Email: forsaa@gmail.com
      • Contact: Birger Lindtjorn, PhD; Phone Number: +4795826869; Email: birgerl@gmail.com
      • Principal Investigator: Vegard A Forsaa, PhD
      • Sub-Investigator: Birger Lindtjorn
  • Troms
    • Tromsø, Troms, Norway, 9019
      • Recruiting
      • University Hospital of Northern Norway
      • Contact: Kristian A Fossen, MD; Phone Number: +4747029181; Email: kristian.fossen@unn.no
      • Contact: Nina K Angelsen, MD; Email: Nina.Kroll.Angelsen@unn.no
      • Principal Investigator: Kristian A Fossen, MD
      • Sub-Investigator: Nina K Angelsen, MD
  • Tronderlag
    • Trondheim, Tronderlag, Norway, 7030
      • Recruiting
      • St. Olavs University Hospital
      • Contact: Dordi K Austeng, PhD; Phone Number: +4747352135; Email: dordi.austeng@ntnu.no
      • Contact: Terje G Fagerholt, MD; Phone Number: +4793223924; Email: Terje.Giske.Fagerholt@stolav.no
      • Principal Investigator: Dordi K Austeng, PhD
      • Sub-Investigator: Terje G Fagerholt, MD
  • Vestland
    • Bergen, Vestland, Norway, 5021
      • Recruiting
      • Haukeland University Hospital
      • Contact: Joergen G Krohn, PhD; Phone Number: +4790622668; Email: joerkroh@online.no
      • Contact: Pal Varhaug, MD; Phone Number: +4790642717; Email: palvarhaug@helse-bergen.no
      • Principal Investigator: Joergen G Krohn, PhD
      • Sub-Investigator: Pal Varhaug, MD
• Spain
  • La Coruna
    • Santiago De Compostela, La Coruna, Spain, 15706
      • Recruiting
      • Clinical Universitary Hospital of Santiago
      • Contact: Joaquin Marticorena, PhD; Phone Number: +34981951757; Email: jmarticorena@gmail.com
      • Principal Investigator: Maria Jose Teijeiro
      • Sub-Investigator: Joaquin Marticorena
      • Contact: Maria Jose Teijeiro; Phone Number: +34981951757; Email: mjblantei@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gas tamponade; Intravitreal gas tamponade	Device: Postoperative intraocular tamponade; Flushing the eye cavity with a tamponade at the end of surgery
Experimental: Air tamponade; Intravitreal Air tamponade	Device: Postoperative intraocular tamponade; Flushing the eye cavity with a tamponade at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular hole closure after single surgery	Closure verified on OCT	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in outcome of patient well-being	Questionnaire	4 weeks and 4 months
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: REK 580226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No