Comparison of Two Biometers in Dense Cataracts

Completed

Conditions studied: Cataract

In brief

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 facts

Study ID

NCT07475832

Run by

Berkeley Eye Center

People needed

61

Starts

2023-10-11

Expected to finish

2025-10-15

Last updated by the study team

2026-03-17

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 45 years and older
• Previously underwent complex cataract removal by phacoemulsification with a clear corneal incision in one or both eyes more than 1 month before enrollment
• Complex cataract removal was performed for poor red reflex or poor visualization due to lens density or opacification
• Pre-operative dense cataract in the study eye, defined as greater than or equal to 3+ posterior subcapsular cataract, 3+ nuclear sclerotic cataract, 3+ cortical cataract, or any combination of these
• Pre-operative biometry performed with both the ARGOS and IOLMaster 700
• Other than cataract, clear intraocular media, with no corneal opacity or vitreous hemorrhage

You may not qualify if…

• Pre-operative mature or white cataract in the study eye
• Any corneal abnormality, other than regular corneal astigmatism, that in the opinion of the investigator would confound study outcomes
• History of or current retinal condition, or predisposition to retinal conditions, other than posterior vitreous detachment, that in the opinion of the investigator would confound study results
• Amblyopia or strabismus in either eye
• Nystagmus or other condition that would hamper axial length capture because of poor fixation
• History of or current anterior or posterior segment inflammation of any etiology
• Any form of ocular neovascularization
• Diagnosed degenerative eye disorders
• Acute or chronic disease or illness that, in the opinion of the investigator, would confound study results, including immunocompromised state, connective tissue disease, or clinically significant atopic disease

Where it is running

• Berkeley Eye Center - Sugar Land — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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