Hyaluronic Acid Gels for Lower Lid Retraction

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.

Study Overview

• Status: Withdrawn
• Conditions: Ectropion
• Intervention / Treatment: Procedure: Hyaluronic acid; Procedure: Saline

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Jules Stein Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid; Patients in this arm will receive hyaluronic acid fillers to the lower lid.	Procedure: Hyaluronic acid; Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position; Other Names: Restylane
Sham Comparator: Saline	Procedure: Saline; Saline will be injected in to the lower lid, elevating it to a more anatomic position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower eyelid position	Decrease in inferior scleral show	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective dry eye symptoms	Ocular surface disease index score	6 weeks
Objective dry eye signs	NEI dry eye score	6 weeks
Objective dry eye signs	Oxford staining score	6 weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Daniel B Rootman, MD, MSc, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Keratoconjunctivitis Sicca; Ectropion; Lower eyelid retraction
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Ectropion; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 12-001629