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Acellular Dermal Matrix vs Autologous Tarsus for Correction of Lower Eyelid Retraction

RecruitingNAAges 18 Years - 75 YearsAllHaukeland University Hospital
NCT06926686 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare the effectiveness of two promising implants in treatment of lower eyelid retraction in 40 patients. This condition often resulting from injury, surgical complications, or thyroid eye disease. The main questions it aims to answer are: Which implant provides better long-term stability of the eyelid malposition? Does one implant minimize complications and improve patient outcomes more effectively than the other? This study will compare the use of donor sclera implants to a cellular dermal matrix to see if either offers superior results in terms of reducing graft shrinkage and improving eyelid positioning. Participants will: Undergo lower eyelid reconstruction surgery with one of the two implants. Be monitored for postoperative outcomes, including eyelid position, recurrence rates, and complications over a follow-up period 6 months.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Autologous tarsus
  • Acellular dermal matrix
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Where

1 site
Haukeland University Hospital
Bergen, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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