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Hyaluronic Acid Gels for Lower Lid Retraction

NCT ID: NCT01838252

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-05-31

Brief Summary

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Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic. Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be damaging to the cornea. The definitive therapy for lid retraction is surgical, and often involves complicated procedures including tissue grafting.

Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by subcutaneous injection and volume addition. These gels have gained wide popularity in for cosmetic applications in filling volume deficit areas. Functional applications in the periorbital area have also been described including the filling of volume deficit anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG to be useful in correcting both upper and lower eyelid retraction, with good effect.

The purpose of this investigation is to define the clinical utility of HAG correction of lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on cornea) and qualitative effects (symptom severity).

Our hypothesis is that HAG correction of lower eyelid retraction will improve patient comfort, clinical signs of dry eye and aesthetic self image.

Detailed Description

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Conditions

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Ectropion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hyaluronic acid

Patients in this arm will receive hyaluronic acid fillers to the lower lid.

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type PROCEDURE

Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position

Saline

Group Type SHAM_COMPARATOR

Saline

Intervention Type PROCEDURE

Saline will be injected in to the lower lid, elevating it to a more anatomic position

Interventions

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Hyaluronic acid

Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position

Intervention Type PROCEDURE

Saline

Saline will be injected in to the lower lid, elevating it to a more anatomic position

Intervention Type PROCEDURE

Other Intervention Names

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Restylane

Eligibility Criteria

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Inclusion Criteria

1. Lower eyelid retraction of \>1mm in one or both eyes.
2. Complaints of either significant ocular symptoms (OSDI\>13) or cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria

1. Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population
2. Age over 65 years of age: as HAG filler effect may be different in this population
3. Are pregnant or nursing: as there is little safety data on potential teratogenicity of HAG fillers
4. Have a demonstrated allergy to HAG fillers or lidocaine
5. Have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it
6. Have a bleeding disorder or currently taking blood-thinning medications such as Coumadin or heparin on a daily basis.
7. Currently active stage Thyroid Eye Disease
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Daniel Rootman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel B Rootman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Jules Stein Eye Institute

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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12-001629

Identifier Type: -

Identifier Source: org_study_id