CONTOURA vs WFO Ablation PRK & LASIK
ConditionRefractive Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
Sponsor59th Medical Wing
About this trial
This is a prospective randomized contralateral double-masked study. Each patient will be randomized as to which eye undergoes wave-front optimized (WFO) vs. wave-front guided (WFG) during Photorefractive keratectomy (PRK) or Laser-assisted in situ Keratomileusis (LASIK) surgery to determine which ablation profile provides the best visual outcome.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
No meeting requirements for PRK or LASIK
Desiring monovision treatment
Anisometropia >2D spherical equivalent
Prior ocular surgeries / trauma / problem
Trial design
Design model
Parallel
Treatments tested in this trial
Wave-Front Optimized (WFO) ablation vs Topography-guided (TG) ablation
DevicePatient will undergo PRK or LASIK using WFO ablation in one eye and TG ablation on contralateral eye
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: LASIK refractive surgeryExperimental treatment 1 intervention
Group B: PRK refractive surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-operative refractive error
The Post-Operative sphere equivalent refractive error for eyes undergoing Wave-Front Optimized (WFO) ablation vs Topography-guided ablation
Time frame
6 months post-surgerySecondary outcomes
1
Post-operative Uncorrected Visual Acuity
The Post-Operative visual acuity for eyes undergoing Wave-Front Optimized (WFO) ablation vs Topography-guided ablation
Time frame
6 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov