Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06926686

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

Led by Haukeland University Hospital · Updated on 2025-04-17

40

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18-75 years
  • Grade 2 or higher lower eyelid retraction
  • Candidate for surgical correction due to functional or cosmetic reasons
  • Willingness to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Active ocular or eyelid infection
  • History of severe scarring or keloid formation
  • Concurrent orbital or eyelid malignancies
  • Pregnancy or lactation
  • Uncontrolled systemic diseases such as diabetes or immune disorders
  • Previous eyelid surgery on the affected eye

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Haukeland University Hospital

Bergen, Vetslandet, Norway, 5021

Actively Recruiting

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Research Team

H

Hans Olav Ueland, MD, PhD

CONTACT

A

Annette Morwena Hope, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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