Trial Outcomes & Findings for Corneal Topographer Fluorescein Patterns (NCT NCT00584285)

NCT ID: NCT00584285

Last Updated: 2018-11-02

Results Overview

Comparison of fluorescein patterns of rgp contact lens. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns using standard clinical means.

• Recruitment status: COMPLETED
• Target enrollment: 18 participants
• Primary outcome timeframe: Baseline first visit
• Results posted on: 2018-11-02

Participant Flow

Participant milestones

Measure	Corneal Topographer Flourscein Patterns Use corneal topography to evaluate fluorescein pattern of rgp contact lens Comparison of fluorescein patterns: Compare trial contact lens fitting to fitting contact lenses based on corneal topography measurement
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Corneal Topographer Fluorescein Patterns

Baseline characteristics by cohort

Measure	Corneal Topographer Flourscein Patterns n=18 Participants Use corneal topography to evaluate fluorescein patter of rgp contact lens Comparison of fluorescein patterns: Compare trial contact lens fitting to fitting contact lenses based on corneal topography measurement
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline first visit

Comparison of fluorescein patterns of rgp contact lens. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns using standard clinical means.

Outcome measures

Measure	Corneal Topographer Flourscein Patterns n=18 Participants Use corneal topography to evaluate fluorescein pattern of rgp contact lens Comparison of fluorescein patterns: Compare conventional contact lens fitting to fitting contact lenses based on corneal topography measurement
Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns	0 participants

Adverse Events

Corneal Topographer Flourscein Patterns

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine W. Sindt

University of Iowa

Phone: 319-356-2916

Email: christine-sindt@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place