Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye

NCT01161771 | Completed Results

• 1 other identifier: MA-RES-09-004
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured

  The percentage of subjects at month 3 with corneal sensitivity \< 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.

  Month 3

Secondary Outcomes (5)

• Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3

  Baseline, Month 3

• Change From Baseline in Corneal Staining at Month 3

  Baseline, Month 3

• Change From Baseline in Conjunctival Staining at Month 3

  Baseline, Month 3

• Change From Baseline in Tear Break-Up Time at Month 3

  Baseline, Month 3

• Change From Baseline in Schirmer's Test at Month 3

  Baseline, Month 3

Study Arms (1)

Patients with cataract and corneal astigmatism

Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)

Procedure: Cataract Surgery and Limbal relaxing incision

Interventions

Cataract Surgery and Limbal relaxing incision PROCEDURE

Cataract extraction and limbal-relaxing incisions

Patients with cataract and corneal astigmatism

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cataract extraction and limbal relaxing incision

You may qualify if:

• Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism

You may not qualify if:

• Uncontrolled systemic disease
• Have undergone refractive surgery or any surgery involving a limbal or corneal incision
• Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
• Temporary or permanent occlusion of the lacrimal puncta

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Long Island City, New York, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Vice President, Global Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 14, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 26, 2012
• Results First Posted: July 26, 2012

Record last verified: 2012-07

Locations

US (1)