RECRUITING

Spacer Graft Study

Conditions

Eyelid Diseases Eyelid Droop Retraction Repair Hard Palate Autologous Ear Cartilage porcine acellular dermal matrix spacer graft

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Study Protocol for Comparison of Lower Eyelid Retraction Repair With Hard Palate, Autologous Ear Cartilage, and Porcine Acellular Dermal Matrix Spacer Grafts

Quick Facts

Study Start:2021-08-01

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04140734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients will be included if they undergo lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022 .	* Patients will be excluded if they are 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. In addition, 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.

Inclusion Criteria

Exclusion Criteria

* Patients will be included if they undergo lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022 .

* Patients will be excluded if they are 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. In addition, 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.

Contacts and Locations

Study Contact

Anne Barmettler, MD

CONTACT

(978) 886-7122

abarmett@montefiore.org

Principal Investigator

Anne Barmettler, MD

PRINCIPAL_INVESTIGATOR

Director of Oculoplastic Surgery Division

Study Locations (Sites)

Montefiore Medical Center

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Anne Barmettler, MD, PRINCIPAL_INVESTIGATOR, Director of Oculoplastic Surgery Division

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01

Study Completion Date2027-07

Study Record Updates

Study Start Date2021-08-01

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

Retraction Repair
Hard Palate
Autologous Ear Cartilage
porcine acellular dermal matrix
spacer graft

Additional Relevant MeSH Terms

Eyelid Diseases
Eyelid Droop