Patient Reported Outcomes With WaveLight Plus LASIK

Not yet recruiting

• Conditions: Myopia; Astigmatism

• Registration Number: NCT07084844
• Lead Sponsor: Mann Eye Institute

Brief Summary

This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Study Start: 2025-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Between the ages of 18 and 39

• Meet the standard care requirements for LASIK

• Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters

• Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism

• SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D

• Minimum residual stromal bed thickness of 250 µm

• If currently wearing contact lenses:

  • Soft CTL wearers discontinue for minimum 3 days
  • RGP CTL wearers discontinue for 1 month per decade of wear

• Stable refraction (2 consecutive manifest refractions within 0.25 SE)

• Stable K readings (2 consecutive K readings in 2 consecutive visits)

• Willing and able to complete all post-operative visits

• Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm

Exclusion Criteria

• Subjects with any prior ocular surgery
• Subjects with topographic evidence of keratoconus, or ectasia
• Subjects with autoimmune diseases
• Subjects who are pregnant or nursing
• Systemic disease likely to affect wound healing, such as diabetes and severe atopy
• Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only).	3 months postoperative

Secondary Outcome Measures

Name	Time	Method
PROWL-SS Questionnaire	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).
OSDI Score	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.
Uncorrected distance visual acuity	3 months postoperative	% of eyes in each level of uncorrected visual acuity (e.g. 20/20, 20/16, 20/12.5, 20/10 with logMAR chart).

Trial Locations

Locations (1)

Mann Eye Institute; 🇺🇸 Houston, Texas, United States