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

NCT06926686 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-17

No results posted yet for this study

Summary

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

  • Lower Eyelid Retraction

Interventions

PROCEDURE

Autologous tarsus

Surgical implantation of autologous tarsus to the lower eyelid

PROCEDURE

Acellular dermal matrix

Surgical implantation of acellular dermal matrix to the lower eyelid

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Hans Olav Ueland, MD, PhD · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2030-01-01
Completion
2032-01-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06926686 on ClinicalTrials.gov