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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Glostrup Municipality, Copenhagen) |
| Status | Recruiting |
| Started | April 30, 2023 |
| Main results expected | April 1, 2025 |
| Study ends | April 1, 2028 |
| Registry record updated | April 16, 2024 |
| Trial ID | NCT05828251 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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.