Eyelid DiseasesNCT04140734
Spacer Graft Study
A study testing Spacer Graft in people with Eyelid Diseases and Eyelid Droop, run by Montefiore Medical Center at 1 site in United States.
Trial summary
To determine which of three types of spacer grafts (hard palate vs autologous ear cartilage vs Enduragen) are the most effective in lower eyelid retraction repair outcomes as measured by MRD2 (margin to reflex distance 2) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eyelid Diseases, Eyelid Droop
- What is being tested?
- Spacer Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to Jul 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Underwent lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022
Who cannot join
- Younger than 18 years old
- Required concurrent surgeries (e.g., midface lift or full thickness skin graft) or required further surgeries on the operated eyelid within the 6 months postoperatively
- Patients with less than 1-month follow up will be excluded from all outcome analysis and those without postoperative 6-month data will be excluded from the postoperative month 6 MRD2 calculation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
To determine which of three types of spacer grafts (hard palate vs autologous ear cartilage vs Enduragen) are the most effective in lower eyelid retraction repair outcomes as measured by MRD2 (margin to reflex distance 2)
Read the detailed description
Lower eyelid retraction is a common eyelid malposition, typically caused by thyroid eye disease, excessive resection of skin in a cosmetic lower eyelid blepharoplasty, vertical rectus muscle recession, facial nerve paralysis, or a normal anatomical variant. When the lower eyelid is displaced inferiorly, exposing sclera between the limbus and the eyelid margin, symptoms can vary from ocular irritation and discomfort to vision threatening corneal decompensation. If medical management does not suffice, surgery is indicated.
Although lower eyelid retractor lysis alone has been described, supporting material (spacer graft) placed to augment the posterior lamella is generally required for more effective elevation of the eyelid. Various materials have been utilized, including autologous auricular cartilage, bovine acellular dermal matrix, porcine acellular dermal matrix, hard palate mucosa, dermis and dermis fat grafts. Previous studies on acellular dermal matrix use in lower eyelid retraction repair consist of retrospective efficacy studies with only 2 comparative studies. However, conflicting results raised doubt as to which material was superior. In addition, a prospective, randomized comparative study of spacer grafts used for lower eyelid retraction repair was done comparing autologous auricular cartilage, porcine acellular dermal matrix, and bovine acellular dermal matrix. The results yielded no statistically significant difference in surgical outcomes and complications. As of now, surgery with any of the spacer grafts, including autologous hard palate, is accepted as standard of care.
This study is designed to determine whether using hard palate as a spacer graft will have statistically significant different surgical outcomes and complications as compared to autologous ear cartilage and porcine acellular dermal matrix spacer grafts. Although studied separately, this has not been studied before in a prospective randomized manner and may prove to demonstrate improved surgical results and decreased complications. This can guide future choice of spacer graft used in lower eyelid retraction repair surgery.
- Conditions
- Eyelid Diseases, Eyelid Droop
- Being tested
- Spacer Graft
- Keywords
- Retraction Repair, Hard Palate, Autologous Ear Cartilage, porcine acellular dermal matrix, spacer graft
- Medical subject headings
- Eyelid Diseases, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spacer GraftDevice
In this prospective, randomized clinical trial, patients who will already be undergoing lower eyelid retraction repair with a spacer graft will randomly be assigned via a randomization web-site to receive 1 of 3 spacer grafts: hard palate, autologous auricular cartilage, and porcine acellular dermal matrix (Enduragen). Both the patient and the surgeon will know which of the three possible grafts are being used.
| Study group | Role | What they receive |
|---|---|---|
| Hard Palate | Experimental | Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use hard palate Receives: Device: Spacer Graft |
| Autologous Ear Cartilage | Experimental | Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use autologous ear cartilage Receives: Device: Spacer Graft |
| Porcine Acellular Dermal Matrix | Experimental | Some patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use porcine acellular dermal matrix Receives: Device: Spacer Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Eyelid Height
Lower Eyelid Height will be measured via Margin Reflect Distance 2 (MRD2). Photographs taken during study visits will analyze the effectiveness of the spacer grafts with respect to lower eyelid retraction repair. MRD2 is the distance in millimeters between the pupillary light reflex and the lower eyelid margin with the patient looking at a light reflex in primary gaze. Results will be summarized and reported by study arm using basic descriptive statistics. A normal MRD2 is about 4. The higher the number for MRD2, the more severe the retraction. Postoperatively, a lower MRD2 indicates a better surgical outcome.
Measured: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively
Secondary outcomes (1)
Post-Surgical Complications
Post-Surgical Complications will be summarized using specific complications as graded by either the examiner or the patient. Specifically, conjunctival injection and eyelid swelling will be graded by the examiner on a scale of 0 to 10 where "0" indicates no visible injection or swelling (normal), respectively and "10" is indicative of the most severe level of conjuctival redness or swelling, respectively. Similarly, tearing, itching, and discomfort will be individually graded by the patient on a scale of 0-10 wherein "0" is indicative of no tearing, itching, or discomfort, respectively and "10" is indicative of maximal tearing, itching, and discomfort, respectively. Results will be summarized and reported by study arm using basic descriptive statistics.
Measured: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Aug 2021
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (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 Eyelid DiseasesStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Barmettler, MD, Principal investigator, Director of Oculoplastic Surgery Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140734
- Sponsor's protocol ID
- 2019-10410
- Other IDs
- 2019
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bartley GB. The differential diagnosis and classification of eyelid retraction. Ophthalmology. 1996 Jan;103(1):168-76. doi: 10.1016/s0161-6420(96)30744-6.
PubMed 8628549Baylis HI, Nelson ER, Goldberg RA. Lower eyelid retraction following blepharoplasty. Ophthalmic Plast Reconstr Surg. 1992;8(3):170-5. doi: 10.1097/00002341-199209000-00002.
PubMed 1390423Barmettler A, Heo M. A Prospective, Randomized Comparison of Lower Eyelid Retraction Repair With Autologous Auricular Cartilage, Bovine Acellular Dermal Matrix (Surgimend), and Porcine Acellular Dermal Matrix (Enduragen) Spacer Grafts. Ophthalmic Plast Reconstr Surg. 2018 May/Jun;34(3):266-273. doi: 10.1097/IOP.0000000000000946.
PubMed 28658181Wearne MJ, Sandy C, Rose GE, Pitts J, Collin JR. Autogenous hard palate mucosa: the ideal lower eyelid spacer? Br J Ophthalmol. 2001 Oct;85(10):1183-7. doi: 10.1136/bjo.85.10.1183.
PubMed 11567962Liao YL, Wu SY, Tsai YJ. Long-Term Results of Autologous Auricular Cartilage Graft Applied in Anophthalmic Orbits Unable to Wear Prosthesis. J Ophthalmol. 2019 Apr 9;2019:7197063. doi: 10.1155/2019/7197063. eCollection 2019.
PubMed 31093371
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts
- ClinicalTrials.gov ID
- NCT04140734
- Acronym / sponsor ID
- 2019-10410
- Conditions
- Eyelid Diseases, Eyelid Droop
- Keywords
- Retraction Repair, Hard Palate, Autologous Ear Cartilage, porcine acellular dermal matrix, spacer graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Oct 2019 (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.
To determine which of three types of spacer grafts (hard palate vs autologous ear cartilage vs Enduragen) are the most effective in lower eyelid retraction repair outcomes as measured by MRD2 (margin to reflex distance 2)
Detailed description
Lower eyelid retraction is a common eyelid malposition, typically caused by thyroid eye disease, excessive resection of skin in a cosmetic lower eyelid blepharoplasty, vertical rectus muscle recession, facial nerve paralysis, or a normal anatomical variant. When the lower eyelid is displaced inferiorly, exposing sclera between the limbus and the eyelid margin, symptoms can vary from ocular irritation and discomfort to vision threatening corneal decompensation. If medical management does not suffice, surgery is indicated.
Although lower eyelid retractor lysis alone has been described, supporting material (spacer graft) placed to augment the posterior lamella is generally required for more effective elevation of the eyelid. Various materials have been utilized, including autologous auricular cartilage, bovine acellular dermal matrix, porcine acellular dermal matrix, hard palate mucosa, dermis and dermis fat grafts. Previous studies on acellular dermal matrix use in lower eyelid retraction repair consist of retrospective efficacy studies with only 2 comparative studies. However, conflicting results raised doubt as to which material was superior. In addition, a prospective, randomized comparative study of spacer grafts used for lower eyelid retraction repair was done comparing autologous auricular cartilage, porcine acellular dermal matrix, and bovine acellular dermal matrix. The results yielded no statistically significant difference in surgical outcomes and complications. As of now, surgery with any of the spacer grafts, including autologous hard palate, is accepted as standard of care.
This study is designed to determine whether using hard palate as a spacer graft will have statistically significant different surgical outcomes and complications as compared to autologous ear cartilage and porcine acellular dermal matrix spacer grafts. Although studied separately, this has not been studied before in a prospective randomized manner and may prove to demonstrate improved surgical results and decreased complications. This can guide future choice of spacer graft used in lower eyelid retraction repair surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hard Palate | Experimental | Device: Spacer GraftSome patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use hard palate |
| Autologous Ear Cartilage | Experimental | Device: Spacer GraftSome patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use autologous ear cartilage |
| Porcine Acellular Dermal Matrix | Experimental | Device: Spacer GraftSome patients who will already be undergoing lower eyelid retraction repair with a spacer graft will be randomized to use porcine acellular dermal matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Underwent lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022
Key exclusion criteria (3 listed)
- Younger than 18 years old
- Required concurrent surgeries (e.g., midface lift or full thickness skin graft) or required further surgeries on the operated eyelid within the 6 months postoperatively
- Patients with less than 1-month follow up will be excluded from all outcome analysis and those without postoperative 6-month data will be excluded from the postoperative month 6 MRD2 calculation
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 |
|---|---|---|
| Spacer GraftIn this prospective, randomized clinical trial, patients who will already be undergoing lower eyelid retraction repair with a spacer graft will randomly be assigned via a randomization web-site to receive 1 of 3 spacer grafts: hard palate, autologous auricular cartilage, and porcine acellular dermal matrix (Enduragen). Both the patient and the surgeon will know which of the three possible grafts are being used. | Device | Autologous Ear Cartilage, Hard Palate, Porcine Acellular Dermal Matrix |
Primary outcome
Lower Eyelid Height
Time frame: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively
Lower Eyelid Height will be measured via Margin Reflect Distance 2 (MRD2). Photographs taken during study visits will analyze the effectiveness of the spacer grafts with respect to lower eyelid retraction repair. MRD2 is the distance in millimeters between the pupillary light reflex and the lower eyelid margin with the patient looking at a light reflex in primary gaze. Results will be summarized and reported by study arm using basic descriptive statistics. A normal MRD2 is about 4. The higher the number for MRD2, the more severe the retraction. Postoperatively, a lower MRD2 indicates a better surgical outcome.
1 secondary outcome
Post-Surgical Complications
Time frame: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively
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 21 Apr 2026.
- Background: PubMed 8628549Bartley GB. The differential diagnosis and classification of eyelid retraction. Ophthalmology. 1996 Jan;103(1):168-76. doi: 10.1016/s0161-6420(96)30744-6.
- Background: PubMed 1390423Baylis HI, Nelson ER, Goldberg RA. Lower eyelid retraction following blepharoplasty. Ophthalmic Plast Reconstr Surg. 1992;8(3):170-5. doi: 10.1097/00002341-199209000-00002.
- Background: PubMed 28658181Barmettler A, Heo M. A Prospective, Randomized Comparison of Lower Eyelid Retraction Repair With Autologous Auricular Cartilage, Bovine Acellular Dermal Matrix (Surgimend), and Porcine Acellular Dermal Matrix (Enduragen) Spacer Grafts. Ophthalmic Plast Reconstr Surg. 2018 May/Jun;34(3):266-273. doi: 10.1097/IOP.0000000000000946.
- Background: PubMed 11567962Wearne MJ, Sandy C, Rose GE, Pitts J, Collin JR. Autogenous hard palate mucosa: the ideal lower eyelid spacer? Br J Ophthalmol. 2001 Oct;85(10):1183-7. doi: 10.1136/bjo.85.10.1183.
- Background: PubMed 31093371Liao YL, Wu SY, Tsai YJ. Long-Term Results of Autologous Auricular Cartilage Graft Applied in Anophthalmic Orbits Unable to Wear Prosthesis. J Ophthalmol. 2019 Apr 9;2019:7197063. doi: 10.1155/2019/7197063. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Anne Barmettler, MD principal investigator
Director of Oculoplastic Surgery Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spacer Graft in people with Eyelid Diseases and Eyelid Droop, run by Montefiore Medical Center at 1 site in United States.
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 1 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 21 Apr 2026. 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 United States. 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 Anne Barmettler, MD ((978) 886-7122, abarmett@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Eyelid Height (time frame: Preoperatively, and at 1 week, 1 month, 3 months and 6 months post-operatively). 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 NCT04140734, 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 21 Apr 2026.