Cataract
Conditions
Keywords
Biometry, IOL Calculations
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).
Interventions
DEVICEARGOS Biometer
The ARGOS biometer uses swept-source optical coherence tomography (SS-OCT) with a 1060 nm tunable laser to capture high-resolution B-scan images of the entire eye. This technology enables sum-of-segments (S-O-S) biometry, measuring each ocular component-corneal thickness, aqueous depth, lens thickness, and vitreous length-individually and summing these values to determine total axial length. SS-OCT provides deep tissue penetration while simultaneously capturing keratometry, white-to-white, and pupillometry data in a single scan. For keratometry measurements, the ARGOS uniquely employes SS-OCT-based telecentric keratometry, which involves projection of 16 infrared LEDs in a wider 3.0 mm ring pattern onto the cornea and calculates curvature from those reflections.
Sponsors
Vance Thompson Vision
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 6. Eyes with intraoperative or postoperative complications 7. Eyes with BCDVA worse than 20/100 preoperatively 8. Subjects who are pregnant or plan to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Outcomes | 12 weeks | To evaluate visual in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations. |
| Refractive Outcomes | 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. |
Countries
United States
Outcome results
None listed