Treatment options for full thickness macular holes
Full Thickness Macular Hole; Should it be Handled Subacutely?
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Glostrup Municipality, Copenhagen) |
| Trial ID | NCT05828251 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with idiopathic full thickness macular holes and specific symptom durations.
Not a fit: Patients with high myopia, traumatic macular holes, or prior ocular surgeries may not benefit from this study.
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 performed: Previous studies have shown varying success with combined surgical approaches for similar conditions, but this specific comparison is novel.
Eligibility criteria
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 this trial is running
Glostrup Municipality, Copenhagen
- Rigshospitalet, Denmark — Glostrup Municipality, Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Morten Dornonville de la Cour, MD, Prof. — Rigshospitalet, Denmark
- Study coordinator: Asrin Rasul, MD
- Email: asrin.rasul@regionh.dk
- Phone: 004522365420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.