Comparing two implants for correcting lower eyelid drooping
Prospective Comparison of Acellular Dermal Matrix and Autologous Tarsus for Correction of Lower Eyelid Retraction
This study is testing which of two types of implants works better for fixing droopy lower eyelids in patients after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vetslandet) |
| Trial ID | NCT06926686 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different implants for the surgical correction of lower eyelid retraction in 40 patients. The study compares acellular dermal matrix and autologous tarsus to determine which implant offers better long-term stability and minimizes complications. Participants will undergo eyelid reconstruction surgery and will be monitored for postoperative outcomes, including eyelid position and recurrence rates, over a six-month follow-up period. The goal is to identify the optimal graft material for improving eyelid positioning and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with grade 2 or higher lower eyelid retraction who require surgical correction.
Not a fit: Patients with active ocular infections, severe scarring, or uncontrolled systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques for correcting lower eyelid retraction, enhancing patient comfort and visual outcomes.
How similar studies have performed: While there is limited data on the specific comparison of these two grafts, similar studies have shown promising results with various spacer grafts for eyelid retraction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18-75 years. * Grade 2 or higher lower eyelid retraction (according to the retraction grading scale). * Candidate for surgical correction due to functional or cosmetic reasons. * Willingness to participate and provide informed consent. Exclusion Criteria: * Active ocular or eyelid infection. * History of severe scarring or keloid formation. * Concurrent orbital or eyelid malignancies. Pregnancy or lactation. Uncontrolled systemic diseases (e.g., diabetes, immune disorders). Previous eyelid surgery on the affected eye.
Where this trial is running
Bergen, Vetslandet
- Haukeland University Hospital — Bergen, Vetslandet, Norway (Recruiting)
Study contacts
- Principal investigator: Hans Olav Ueland, MD, PhD — Haukeland University Hospital
- Study coordinator: Hans Olav Ueland, MD, PhD
- Email: uela@helse-bergen.no
- Phone: +4755975719
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.