Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Treatment options for full thickness macular holes

Official title: Full Thickness Macular Hole; Should it be Handled Subacutely?

Run by Copenhagen University Hospital, Rigshospitalet · NCT05828251 · Data updated 2026-11-12

This study is testing two different surgery methods for treating full thickness macular holes to see which one helps people see better with fewer problems.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment56 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Glostrup Municipality, Copenhagen)
StatusRecruiting
StartedApril 30, 2023
Main results expectedApril 1, 2025
Study endsApril 1, 2028
Registry record updatedApril 16, 2024
Trial IDNCT05828251 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with idiopathic full thickness macular holes and specific symptom durations.

Probably not a fit

Patients with high myopia, traumatic macular holes, or prior ocular surgeries may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the management of full thickness macular holes (FTMH), a condition that leads to central vision loss. It compares the outcomes of sequential cataract surgery followed by vitrectomy against a combined phaco-vitrectomy approach. The study aims to determine the optimal timing and method for surgical intervention to improve visual outcomes while minimizing complications. Patients with varying durations of symptoms will be included to assess the effectiveness of these surgical strategies.

Why it matters

Potential benefit: If successful, this study could enhance visual recovery and reduce complications for patients with full thickness macular holes.

How similar studies have gone: Previous studies have shown varying success with combined surgical approaches for similar conditions, but this specific comparison is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Idiopathic full thickness macular hole
* Duration of symptoms of \<30 days for Group 1 and 2
* Duration of symptoms of 3-12 months for Group 3
* FTMH size \<400µm
* \>18 years
* Able to give informed consent
* Compliance for postoperative positioning

Exclusion Criteria:

* High myopia (≤-3)
* Traumatic macular hole
* Prior ocular surgery, including cataract surgery
* Other ocular diseases compromising the visual acuity (i.e., AMD, diabetic retinopathy, previous vein occlusion)
* Posterior vitreous detachment (Weiss ring)

Where it's running

  • Rigshospitalet, Denmark
    Glostrup Municipality, Copenhagen, Denmark
    Recruiting

Study contacts

  • Principal investigator: Morten Dornonville de la Cour, MD, Prof. — Copenhagen University Hospital, Rigshospitalet
  • Study coordinator: Asrin Rasul, MD
  • Email: asrin.rasul@regionh.dk
  • Phone: 004522365420

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.