An observational study in Cataract, sponsored by Berkeley Eye Center. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Berkeley Eye Center · Observational
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.
Cataract surgery is the most commonly performed surgical procedure in the United States. Accurate axial length measurement is critical for intraocular lens power selection, but optical biometry can be challenging in eyes with dense cataracts because of poor media penetration and limited signal acquisition. When optical axial length measurement cannot be obtained, manual immersion A-scan ultrasonography is often required, which adds workflow complexity, technician time, and patient time.
This study was designed to evaluate the performance of the ARGOS swept-source optical coherence tomography biometer in eyes with dense cataracts and to compare its axial length acquisition capability with that of the IOLMaster 700. The study also evaluates whether use of ARGOS, including enhanced retina visualization mode when needed, may reduce reliance on manual ultrasound biometry in this setting.
This is a single-center, ambispective, non-interventional observational study. The retrospective component involves review of prior cataract surgery cases in which pre-operative biometry had been performed with both the ARGOS and the IOLMaster 700 in eyes with dense cataracts associated with poor visualization or poor red reflex. The prospective component consists of a postoperative study visit in enrolled subjects for repeat biometry, allowing comparison of postoperative measurements with historical pre-operative values and assessment of whether successful ARGOS measurement could have reduced the need for confirmatory ultrasound testing.
The overall purpose of the study is to better characterize the utility of ARGOS biometry in dense cataracts and to assess its potential clinical value in reducing the need for manual A-scan ultrasonography in routine practice.
Pseudophakic adults who previously underwent complex cataract surgery for poor red reflex or poor visualization due to dense cataract and had pre-operative biometry with both the ARGOS and IOLMaster 700.
Exclusion Criteria:
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.
Diagnostic Test: ARGOS biometer · Diagnostic Test: IOLMaster 700
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.
Swept-source optical coherence tomography biometer used for axial length measurement pre-operatively and at the postoperative study visit for comparison with ARGOS measurements.
Percentage of eyes with successful axial length acquisition
Percentage of eyes in which axial length measurements were successfully acquired using the ARGOS biometer compared with the IOLMaster 700 in eyes with dense cataracts.
Time frame: Pre-operative assessment and postoperative confirmation visit, up to 24 months after cataract surgery.
Percentage of eyes requiring ultrasound A-scan
Percentage of eyes that required manual ultrasound A-scan because axial length measurement could not be obtained by optical biometry.
Time frame: Pre-operative review and postoperative confirmation visit, up to 24 months after cataract surgery.
Percentage of eyes requiring enhanced retina visualization mode
Percentage of eyes in which enhanced retina visualization (ERV) mode was required to obtain axial length measurement.
Time frame: Pre-operative review and postoperative confirmation visit, up to 24 months after cataract surgery.
Difference between postoperative and pre-operative axial length measurements
Difference between postoperative axial length measurements and pre-operative axial length measurements for ARGOS and IOLMaster 700.
Time frame: Up to 24 months postoperatively.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Berkeley Eye Center