CataractNCT07475832
Comparison of Two Biometers in Dense Cataracts
An observational study of Cataract, run by Berkeley Eye Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- ARGOS biometer and IOLMaster 700
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Berkeley Eye Center - Sugar Land
Sugar Land, Texas, 77478
About this study
Official title: Comparison of Two Swept-Source Optical Coherence Tomography Biometers in Dense Cataracts
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.
Read the detailed description
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.
- Conditions
- Cataract
- Being tested
- ARGOS biometer, IOLMaster 700
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGOS biometerDiagnostic 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 700Diagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ARGOS biometer; Diagnostic Test: IOLMaster 700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative assessment and postoperative confirmation visit, up to 24 months after cataract surgery.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start11 Oct 2023
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berkeley Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475832
- Sponsor's protocol ID
- 78171657
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Swept-Source Optical Coherence Tomography Biometers in Dense Cataracts
- ClinicalTrials.gov ID
- NCT07475832
- Acronym / sponsor ID
- 78171657
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible pseudophakic subjects with prior dense cataracts | – | Diagnostic Test: ARGOS biometer, Diagnostic Test: IOLMaster 700Pseudophakic 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGOS biometerSwept-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. | Diagnostic test | Eligible pseudophakic subjects with prior dense cataracts |
| IOLMaster 700Swept-source optical coherence tomography biometer used for axial length measurement pre-operatively and at the postoperative study visit for comparison with ARGOS measurements. | Diagnostic test | Eligible pseudophakic subjects with prior dense cataracts |
Primary outcome
Percentage of eyes with successful axial length acquisition
Time frame: Pre-operative assessment and postoperative confirmation visit, up to 24 months after cataract surgery.
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.
3 secondary outcomes
Percentage of eyes requiring ultrasound A-scan
Time frame: Pre-operative review and postoperative confirmation visit, up to 24 months after cataract surgery.
Percentage of eyes requiring enhanced retina visualization mode
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
Time frame: Up to 24 months postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Berkeley Eye Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.