Trial Outcomes & Findings for Patient Reported Outcomes With WaveLight LASIK (NCT NCT06668909)

Results Overview

Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

12 months postoperatively

Results posted on

2026-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser).
Overall Study STARTED	300
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This was an ambispective study, sex data was not collected.

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 months postoperatively

Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).

Outcome measures

Outcome measures
Measure	All Participants n=300 Participants This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser).
Patient Satisfaction	285 Participants

SECONDARY outcome

Timeframe: 12 months postoperatively

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.

Outcome measures

Outcome measures
Measure	All Participants n=300 Participants This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser).
PROWL Questionnaire Always" or "Often" experiencing glare	18 Participants
PROWL Questionnaire Always" or "Often" experiencing double images	3 Participants
PROWL Questionnaire Always" or "Often" experiencing halos	12 Participants
PROWL Questionnaire Always" or "Often" experiencing starbursts	33 Participants

SECONDARY outcome

Timeframe: 12 months postoperatively

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	All Participants n=300 Participants This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser).
OSDI Questionnaire	8.7 score on a scale (0 to 100) Standard Deviation 8.2

SECONDARY outcome

Timeframe: 12 months postoperatively

Outcome measures

Outcome measures
Measure	All Participants n=300 Participants This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser).
Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.	12 Participants

Adverse Events

All Participants

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

Mark C. Lobanoff

OVO Lasik and Lens LLC

Phone: +1-952-204-9711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place