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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARGOS Biometer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive Outcomes | To evaluate refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations. | 12 weeks |
| Visual Outcomes | To evaluate visual in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Male or females undergoing uncomplicated cataract surgery with a history of myopic corneal laser refractive surgery and subjects electing to undergo implantation with a monofocal/non-toric IOL
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| Name | Affiliation | Role |
|---|---|---|
| John Berdahl, MD | Vance Thompson Vision Clinic Prof. LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision Clinic, Prof. LLC | Sioux Falls | South Dakota | 57108 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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