Contoura With Phorcides Compared to Wavefront Optimized LASIK

• Sponsor: Daniel Terveen (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05486546
• Collaborator: Alcon Research (Industry)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.5
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief Summary

Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism	Procedure: Contoura with Phorcides; Device: WaveLight Wavefront Optimized	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
• Anticipated Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study: Phorcides Contoura with Phorcides used for surgical planning of LASIK procedure	Procedure: Contoura with Phorcides; Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine
Active Comparator: Control: Wavefront Optimized WaveLight Wavefront Optimized used for surgical planning of LASIK procedure	Device: WaveLight Wavefront Optimized; Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Outcome Measures

Primary Outcome Measures

1. Post-Op UDVA [3 months post-op]

   Percent of participants with monocular UDVA of 20/16 or better

Secondary Outcome Measures

1. Post-OP BCVA [3 months post-op]

   Percent of participants with monocular and binocular BCVA of 20/16 or better

2. Residual Refractive Error [3 months post-op]

   Residual astigmatism and residual SE

3. Low Contrast Visual Acuity [3 months post-op]

   25% low contrast visual acuity post-op

4. Pre-op and post-op visual acuity [3 months post-op]

   Percent of participants with post-op UDVA equal to or better than their pre-op CDVA

5. Corrected Distance Visual Acuity [3 months post-op]

   Compare percent of participants with post-operative and pre-operative CDVA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 38 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients at least age 21 years of age undergoing LASIK eye surgery

• Willing and able to comprehend informed consent and complete 1 month post-op visit

• Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

• Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)

• Both eyes targeted for plano

• Pre-operative total corneal Pachymetry 490um or above

• Stable refractive error <0.50D change in preceding year

• Good general and ocular health

• Pre-operative exam completed within three months of surgery

• SCL discontinued 3 days prior to pre-op exam and the procedure

• Pachymetry above 490 with residual greater than 270um

• Candidates who, as determined by the investigator, can safely undergo LASIK

Exclusion Criteria:

• Patients under 21 years of age

• Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon

• Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)

• Pachymetry below 490

• Autoimmune or immunodeficiency diseases

• Pregnant or nursing women

• Patients with signs of inability to understand consent for study and procedure planned

• Patients with history of previous ocular surgery

• Patients with strabismus or amblyopia

• Patients that have a BCDVA of 20/25 or worse in either eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57108

Sponsors and Collaborators

• Daniel Terveen
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Terveen, Principal Investigator, Vance Thompson Vision
• ClinicalTrials.gov Identifier: NCT05486546
• Other Study ID Numbers: AMPLIO
• First Posted: Aug 3, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Daniel Terveen, Principal Investigator, Vance Thompson Vision: Visual acuity; Refractive outcome; LASIK; Contrast sensitivity; Wavefront Optimized; Topography-guided
• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of Aug 3, 2022