Lower Eyelid RetractionNCT06926686
Acellular Dermal Matrix vs Autologous Tarsus for Correction of Lower Eyelid Retraction
A study testing Autologous tarsus and Acellular dermal matrix in people with Lower Eyelid Retraction, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Eyelid Retraction
- What is being tested?
- Autologous tarsus and Acellular dermal matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2025to 1 Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vetslandet, 5021
Annette Morwena Hope, MD, +4741164804, annette.morwena.hope@helse-bergen.no
Kathrine Halsøy, MD, +4791788483, kathrine.halsoy@helse-bergen.no
About this study
Official title: Prospective Comparison of Acellular Dermal Matrix and Autologous Tarsus for Correction of Lower Eyelid Retraction
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?
Read more
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.
Read the detailed description
The study aims to find the best way to surgically correct lower eyelid retraction, a condition where the lower eyelid droops, leading to eye dryness, irritation, and potential vision problems. This condition can arise from various causes like thyroid eye disease, complications from eyelid or eye socket surgeries, burns, or injuries. The goal of the study is to determine which "spacer" graft works best to lift the eyelid back into its correct position and provide long-lasting results.
Currently, there's no universally agreed-upon optimal spacer-graft for this condition. Surgeons at the department of Ophthalmology at Haukeland University Hospital are conducting a study to compare two promising spacer graft materials: acellular dermal matrix (Permacol), a processed tissue that encourages tissue regeneration, and autologous tarsus, tissue taken from the patient's own upper eyelid.
Forty patients needing surgery for lower eyelid retraction will be inculded in this study. They will be randomly assigned to receive either the Permacol graft or the autologous tarsus graft. The surgical procedure involves making an incision inside the lower eyelid, separating the retractors (muscles that pull the eyelid down), and inserting the chosen spacer graft between the tarsus (the eyelid's supporting structure) and the retractors. This lifts the eyelid to the correct position.
Patients will be followed up for six months after surgery. Doctors will measure the position of the eyelid, how well the eye closes, and signs of dryness or damage to the eye surface. Patients will also be asked about pain/discomfort, and satisfaction with the cosmetic outcome. The study will track any complications, such as infection or recurrence of the eyelid retraction.
The study will compare the two groups to see which graft provides better eyelid positioning, reduces symptoms, and has fewer complications. Statistical analysis will be used to determine if there are significant differences between the two treatment groups.
The results of this study will provide valuable information for surgeons treating lower eyelid retraction, helping them choose the most effective and safe graft material for their patients. The procedures will be performed by experienced surgeons at Haukeland University Hospital, ensuring patient safety. The study adheres to ethical guidelines, and patients will provide informed consent before participating.
- Conditions
- Lower Eyelid Retraction
- Being tested
- Autologous tarsus, Acellular dermal matrix
- Keywords
- eyelid malposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous tarsusProcedure or surgery
Surgical implantation of autologous tarsus to the lower eyelid
Acellular dermal matrixProcedure or surgery
Surgical implantation of acellular dermal matrix to the lower eyelid
| Study group | Role | What they receive |
|---|---|---|
| Autologous tarsus | Active comparator | Surgical implantation to elongate the lower eyelid Receives: Procedure: Autologous tarsus |
| A cellular dermal matrix (Permacol) | Active comparator | Surgical implantation to elongate the lower eyelid Receives: Procedure: Acellular dermal matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial reflex distance 2
Number of patients with ≥ 1 mm reduction in medial reflex distance 2
Measured: From baseline to 6 months follow-up.
Secondary outcomes (4)
Vertical eyelid aperture
Number of patients with ≥ 1 mm reduction in vertical eyelid aperture
Measured: From baseline to 6 months follow-up.
Scleral show
Number of patients with ≥ 1 mm reduction in scleral show
.
Measured: From baseline to 6 months follow-up.
Lagophthalmos
Number of patients with ≥ 1 mm reduction in lagophthalmos
.
Measured: From baseline to 6 months follow-up.
Oxford staining scale
Number of patients with ≥ 1 reduction in Oxford staining scale (objective assessment of keratopathy). Oxford staining scale range from 0-4, and a higher score mean a worse outcome.
.
Measured: From baseline to 6 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lower Eyelid RetractionStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-masked prospective randomized two-armed interventinal study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Olav Ueland, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926686
- Sponsor's protocol ID
- 863946
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study group because concent is not obtained to share personal data.
Publications
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.
PubMed 12610767Tao 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.
PubMed 31899031Park 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.
PubMed 28333254Zucal 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.
PubMed 35130205Osaki 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.
PubMed 35399960
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Acellular Dermal Matrix and Autologous Tarsus for Correction of Lower Eyelid Retraction
- ClinicalTrials.gov ID
- NCT06926686
- Acronym / sponsor ID
- 863946
- Conditions
- Lower Eyelid Retraction
- Keywords
- eyelid malposition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 14 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to find the best way to surgically correct lower eyelid retraction, a condition where the lower eyelid droops, leading to eye dryness, irritation, and potential vision problems. This condition can arise from various causes like thyroid eye disease, complications from eyelid or eye socket surgeries, burns, or injuries. The goal of the study is to determine which "spacer" graft works best to lift the eyelid back into its correct position and provide long-lasting results.
Currently, there's no universally agreed-upon optimal spacer-graft for this condition. Surgeons at the department of Ophthalmology at Haukeland University Hospital are conducting a study to compare two promising spacer graft materials: acellular dermal matrix (Permacol), a processed tissue that encourages tissue regeneration, and autologous tarsus, tissue taken from the patient's own upper eyelid.
Forty patients needing surgery for lower eyelid retraction will be inculded in this study. They will be randomly assigned to receive either the Permacol graft or the autologous tarsus graft. The surgical procedure involves making an incision inside the lower eyelid, separating the retractors (muscles that pull the eyelid down), and inserting the chosen spacer graft between the tarsus (the eyelid's supporting structure) and the retractors. This lifts the eyelid to the correct position.
Patients will be followed up for six months after surgery. Doctors will measure the position of the eyelid, how well the eye closes, and signs of dryness or damage to the eye surface. Patients will also be asked about pain/discomfort, and satisfaction with the cosmetic outcome. The study will track any complications, such as infection or recurrence of the eyelid retraction.
The study will compare the two groups to see which graft provides better eyelid positioning, reduces symptoms, and has fewer complications. Statistical analysis will be used to determine if there are significant differences between the two treatment groups.
The results of this study will provide valuable information for surgeons treating lower eyelid retraction, helping them choose the most effective and safe graft material for their patients. The procedures will be performed by experienced surgeons at Haukeland University Hospital, ensuring patient safety. The study adheres to ethical guidelines, and patients will provide informed consent before participating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-masked prospective randomized two-armed interventinal study
| Arm | Type | Receives |
|---|---|---|
| Autologous tarsus | Active comparator | Procedure: Autologous tarsusSurgical implantation to elongate the lower eyelid |
| A cellular dermal matrix (Permacol) | Active comparator | Procedure: Acellular dermal matrixSurgical implantation to elongate the lower eyelid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous tarsusSurgical implantation of autologous tarsus to the lower eyelid | Procedure or surgery | Autologous tarsus |
| Acellular dermal matrixSurgical implantation of acellular dermal matrix to the lower eyelid | Procedure or surgery | A cellular dermal matrix (Permacol) |
Primary outcome
Medial reflex distance 2
Time frame: From baseline to 6 months follow-up.
Number of patients with ≥ 1 mm reduction in medial reflex distance 2
4 secondary outcomes
Vertical eyelid aperture
Time frame: From baseline to 6 months follow-up.
Scleral show
Time frame: From baseline to 6 months follow-up.
Lagophthalmos
Time frame: From baseline to 6 months follow-up.
Oxford staining scale
Time frame: From baseline to 6 months follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Results publication: PubMed 12610767Ferri 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.
- Results publication: PubMed 31899031Tao 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.
- Results publication: PubMed 28333254Park 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.
- Results publication: PubMed 35130205Zucal 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.
- Results publication: PubMed 35399960Osaki 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study group because concent is not obtained to share personal data.
Related trials for Lower Eyelid Retraction
Recruiting
Spacer Graft Study
Eyelid Diseases, Eyelid Droop
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hans Olav Ueland, MD, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous tarsus and Acellular dermal matrix in people with Lower Eyelid Retraction, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Olav Ueland, MD, PhD (+4755975719, uela@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medial reflex distance 2 (time frame: From baseline to 6 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06926686, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.