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

NCT06926686 | Recruiting

• 1 other identifier: 863946
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

eyelid malposition

Outcome Measures

Primary Outcomes (1)

• Medial reflex distance 2

  Number of patients with ≥ 1 mm reduction in medial reflex distance 2

  From baseline to 6 months follow-up.

Secondary Outcomes (4)

• Vertical eyelid aperture

  From baseline to 6 months follow-up.

• Scleral show

  From baseline to 6 months follow-up.

• Lagophthalmos

  From baseline to 6 months follow-up.

• Oxford staining scale

  From baseline to 6 months follow-up.

Study Arms (2)

Autologous tarsus

ACTIVE COMPARATOR

Surgical implantation to elongate the lower eyelid

Procedure: Autologous tarsus

A cellular dermal matrix (Permacol)

ACTIVE COMPARATOR

Surgical implantation to elongate the lower eyelid

Procedure: Acellular dermal matrix

Interventions

Autologous tarsus PROCEDURE

Surgical implantation of autologous tarsus to the lower eyelid

Autologous tarsus

Acellular dermal matrix PROCEDURE

Surgical implantation of acellular dermal matrix to the lower eyelid

A cellular dermal matrix (Permacol)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Vetslandet, 5021, Norway

RECRUITING

Related Publications (5)

• Ferri M, Oestreicher JH. Treatment of post-blepharoplasty lower lid retraction by free tarsoconjunctival grafting. Orbit. 2002 Dec;21(4):281-8. doi: 10.1076/orbi.21.4.281.8555.

  PMID: 12610767 RESULT

• Tao JP, Aakalu VK, Wladis EJ, Sobel RK, Freitag SK, Foster JA, Yen MT. Bioengineered Acellular Dermal Matrix Spacer Grafts for Lower Eyelid Retraction Repair: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 May;127(5):689-695. doi: 10.1016/j.ophtha.2019.11.011. Epub 2019 Dec 30.

  PMID: 31899031 RESULT

• Park E, Lewis K, Alghoul MS. Comparison of Efficacy and Complications Among Various Spacer Grafts in the Treatment of Lower Eyelid Retraction: A Systematic Review. Aesthet Surg J. 2017 Jul 1;37(7):743-754. doi: 10.1093/asj/sjx003.

  PMID: 28333254 RESULT

• Zucal I, Waldner M, Shojaati G, Schweizer R, Klein HJ, Giovanoli P, Plock JA. Burn Scar Ectropion Correction: Surgical Technique for Functional Outcomes. Ann Plast Surg. 2022 Mar 1;88(3):271-276. doi: 10.1097/SAP.0000000000003047.

  PMID: 35130205 RESULT

• Osaki TH, Monteiro LG, Osaki MH. Management of eyelid retraction related to thyroid eye disease. Taiwan J Ophthalmol. 2022 Feb 14;12(1):12-21. doi: 10.4103/tjo.tjo_57_21. eCollection 2022 Jan-Mar.

  PMID: 35399960 RESULT

Study Officials

• Hans Olav Ueland, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Olav Ueland, MD, PhD

CONTACT

+4755975719; uela@helse-bergen.no

Annette Morwena Hope, MD

CONTACT

+47 41164804; annette.morwena.hope@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-masked prospective randomized two-armed interventinal study

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 14, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2032
• Last Updated: April 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)