Comparison of Two Biometers in Dense Cataracts

Part of paid clinical trials in Sugar Land, Texas.

Sponsor
Berkeley Eye Center
Study ID
NCT07475832
Status
Completed

Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARGOS biometer — DIAGNOSTIC_TEST
    Swept-source optical coherence tomography biometer used for axial length measurement pre-operatively and at the postoperative study visit. Enhanced retina visualization mode may be used when needed.
  • IOLMaster 700 — DIAGNOSTIC_TEST
    Swept-source optical coherence tomography biometer used for axial length measurement pre-operatively and at the postoperative study visit for comparison with ARGOS measurements.

Study Details

This single-center, ambispective, observational study evaluates axial length acquisition in eyes with dense cataracts using the ARGOS swept-source optical coherence tomography biometer compared with the IOLMaster 700. Eligible subjects are pseudophakic adults who previously underwent complex cataract surgery because of poor visualization or poor red reflex from dense lens opacity and who had pre-operative biometry performed with both devices, with or without manual immersion A-scan ultrasonography. Enrolled subjects return for postoperative repeat biometry to confirm pre-operative measurements and to assess whether availability of an ARGOS axial length measurement may reduce the need for manual ultrasound A-scans in similar dense cataract cases. The planned sample size justification estimated that 61 patients were needed for statistical power, while 68 were originally targeted to allow for attrition in the prospective portion.

Key Dates

Start date
Oct 11, 2023
Status verified
Mar 2026
Primary completion
Oct 15, 2025
Completion
Oct 15, 2025

Study Design

Enrollment
61 participants (actual)

Arms

  • Arm: Eligible pseudophakic subjects with prior dense cataracts
    Pseudophakic adult subjects who previously underwent complex cataract surgery because of poor visualization or poor red reflex from dense cataract and who had pre-operative biometry performed with the ARGOS and IOLMaster 700, with or without manual immersion A-scan ultrasonography. Enrolled subjects undergo postoperative repeat biometry for comparison with pre-operative measurements.

Primary Outcome Measure

Percentage of eyes with successful axial length acquisition [ Time Frame: Pre-operative assessment and postoperative confirmation visit, up to 24 months after cataract surgery. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Berkeley Eye Center - Sugar LandSugar LandTexas77478-

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Berkeley Eye Center - Sugar Land· Sugar Land, TX

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