Refractive and Visual Outcomes With the ARGOS Biometer In Eyes With a History of Refractive Surgery: ARGOS Study

Vance Thompson Vision

Status: Completed

Conditions: Cataract

Treatments: Device: ARGOS Biometer

Study type: Observational

Funder types: Other

Identifiers

NCT07129980

ARGO-IIT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Study Participants

Description:

Eligible participants were subjects with a history of prior myopic corneal refractive surgery as confirmed by preoperative corneal topography and imaging. All subjects included in the study underwent traditional cataract surgery with a 2.4 millimeter (mm) corneal incision and were implanted with a standard monofocal intraocular lens. Following the procedure, subjects returned at 8-12 weeks postoperative for a study visit in which a manifest refraction was performed.

Treatment:

Device: ARGOS Biometer