Trial Outcomes & Findings for Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software (NCT NCT05848817)

Results Overview

Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

3 Months Postoperative

Results posted on

2025-07-17

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Contoura LASIK Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK
Overall Study STARTED	50 100
Overall Study COMPLETED	50 100
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contoura LASIK n=50 Participants Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK
Age, Continuous	29.3 years STANDARD_DEVIATION 5.0 • n=50 Participants
Sex: Female, Male Female	30 Participants n=50 Participants
Sex: Female, Male Male	20 Participants n=50 Participants

PRIMARY outcome

Timeframe: 3 Months Postoperative

Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.

Outcome measures

Outcome measures
Measure	Contoura LASIK n=50 Participants Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK
Subject Satisfaction	50 Participants

SECONDARY outcome

Timeframe: 3 Months Postoperative

Outcome measures

Outcome measures
Measure	Contoura LASIK n=100 eyes Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK
Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D	90 eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months Postoperative

PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items).

Outcome measures

Outcome measures
Measure	Contoura LASIK n=50 Participants Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK
PROWL Questionnaire Satisfaction score	94.8 score on a scale (0 to 100) Standard Deviation 8.9
PROWL Questionnaire Double image score	99.4 score on a scale (0 to 100) Standard Deviation 4.6
PROWL Questionnaire Glare score	97.7 score on a scale (0 to 100) Standard Deviation 5.9
PROWL Questionnaire Halo Score	94.2 score on a scale (0 to 100) Standard Deviation 7.4
PROWL Questionnaire Starburst score	93.3 score on a scale (0 to 100) Standard Deviation 8.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months Postoperative

The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.

Outcome measures

Outcome measures
Measure	Contoura LASIK n=50 Participants Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK
OSDI Score	7.5 score on a scale (0 to 100) Standard Deviation 6.7

Adverse Events

Contoura LASIK

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

Phillip Brunson

Mann Eye Institute

Phone: 1-713-580-2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place