Comparing two laser ablation techniques for eye surgery
Topography-guided vs. Wavefront Optimized Corneal Refractive Surgery: A Prospective Contralateral Randomized Double-masked Study
This study is testing which of two laser eye surgery techniques, wave-front optimized or topography-guided, helps people see better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | 59th Medical Wing Federal |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT05037370 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective randomized contralateral double-masked study that aims to compare the visual outcomes of two different laser ablation techniques: wave-front optimized (WFO) and topography-guided (TG) during Photorefractive Keratectomy (PRK) or Laser-assisted in situ Keratomileusis (LASIK) surgery. Patients will be randomized to have one eye treated with WFO and the other with TG, allowing for a direct comparison of the effectiveness of these techniques. The study will involve a thorough preoperative evaluation and education, with a focus on optimizing visual outcomes and minimizing post-operative optical aberrations. The use of advanced technology, such as the VARIO Topolyzer, will help tailor the ablation pattern to individual patients.
Who should consider this trial
Good fit: Ideal candidates are DOD beneficiaries aged 21-50 who meet the requirements for PRK or LASIK and can commit to follow-up visits.
Not a fit: Patients with prior ocular surgeries, significant anisometropia, or those desiring monovision treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved visual outcomes for patients undergoing refractive eye surgery.
How similar studies have performed: Previous studies have shown promising results with similar laser ablation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet requirements for PRK or LASIK i.e., Stable \<= .5 D change MRSE) * DOD beneficiaries age 21-50 years * Local pts (w/i 60 mi) who will be in the area for at least 6 months post surgery * Willing to complete all required follow-up visits Exclusion Criteria: * No meeting requirements for PRK or LASIK * Desiring monovision treatment * Anisometropia \>2D spherical equivalent * Prior ocular surgeries / trauma / problem * History of dry eyes * Hyperopia * Mixed astigmatism * Inability to capture VARIO topolyzer scans * Pregnant (or who plans to be within 6 months after surgery) * Breastfeeding any time during the study * History of herpetic disease
Where this trial is running
San Antonio, Texas
- Joint Warfighter Refractive Surgery Center at WHASC — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Charisma B Evangelista, Md — 59th Medical Wing
- Study coordinator: JOSE E CAPO-APONTE, OD, PhD
- Email: Jose.E.CapoAponte.ctr@health.mil
- Phone: 210-292-2554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.