Refractive and Visual Outcomes With the ARGOS Biometer In Eyes With a History of Refractive Surgery: ARGOS Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vance Thompson Vision
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Refractive Outcomes
Study Overview
Brief Summary
The study is to evaluate the visual and refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery for intraocular lens (IOL) power calculations.
Detailed Description
This was a prospective, single-site, study evaluating the accuracy of the ARGOS biometer in subjects with a history of myopic corneal refractive surgery including Laser-Assisted In Situ Keratomileusis (LASIK) and Photorefractive Keratectomy (PRK).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing uncomplicated cataract surgery with a history of myopic corneal laser refractive surgery
- •Subjects electing to undergo implantation with a monofocal/non-toric IOL
- •Willing and able to comprehend informed consent and complete an 8-week visit.
- •Potential postoperative Corrected Distance Visual Acuity (CDVA) of 20/20 or better in each eye based on Investigator's medical opinion
Exclusion Criteria
- •Concurrent or prior ocular surgery within the previous 12 months.
- •Ocular comorbidity that could reduce the potential postoperative CDVA based on the discretion of the operating surgeon
- •History of hyperopic laser corneal refractive surgery
- •History of radial keratotomy
- •Irregular corneal astigmatism or keratoconus
- •Eyes with intraoperative or postoperative complications
- •Eyes with BCDVA worse than 20/100 preoperatively
- •Subjects who are pregnant or plan to become pregnant during the course of the study.
Outcomes
Primary Outcomes
Refractive Outcomes
Time Frame: 12 weeks
To evaluate refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.
Visual Outcomes
Time Frame: 12 weeks
To evaluate visual in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.
Secondary Outcomes
No secondary outcomes reported