CataractNCT07129980
Refractive and Visual Outcomes With the ARGOS Biometer In Eyes With a History of Refractive Surgery: ARGOS Study
An observational study of Cataract, run by Vance Thompson Vision at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- ARGOS Biometer
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 1 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Patients undergoing uncomplicated cataract surgery with a history of myopic corneal laser refractive surgery
- Subjects electing to undergo implantation with a monofocal/non-toric IOL
- Willing and able to comprehend informed consent and complete an 8-week visit.
- Potential postoperative Corrected Distance Visual Acuity (CDVA) of 20/20 or better in each eye based on Investigator's medical opinion
Who cannot join
- Concurrent or prior ocular surgery within the previous 12 months.
- Ocular comorbidity that could reduce the potential postoperative CDVA based on the discretion of the operating surgeon
- History of hyperopic laser corneal refractive surgery
- History of radial keratotomy
- Irregular corneal astigmatism or keratoconus 6. Eyes with intraoperative or postoperative complications 7. Eyes with BCDVA worse than 20/100 preoperatively 8. Subjects who are pregnant or plan to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, 57108
About this study
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.
Read the detailed description
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).
- Conditions
- Cataract
- Being tested
- ARGOS Biometer
- Keywords
- Biometry, IOL Calculations
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGOS BiometerDevice
Also called Swept Source Optical - Optical coherence tomography (SS-OCT)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ARGOS Biometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start11 Jul 2023
- Primary completion3 Jul 2025
- Study completion1 Aug 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Berdahl, MD, Principal investigator, Vance Thompson Vision Clinic Prof. LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129980
- Sponsor's protocol ID
- ARGO-IIT
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive and Visual Outcomes With the ARGOS Biometer In Eyes With a History of Refractive Surgery: ARGOS Study
- ClinicalTrials.gov ID
- NCT07129980
- Acronym / sponsor ID
- ARGO-IIT
- Conditions
- Cataract
- Keywords
- Biometry, IOL Calculations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 19 Aug 2025 (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.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Device: ARGOS BiometerEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- Patients undergoing uncomplicated cataract surgery with a history of myopic corneal laser refractive surgery
- Subjects electing to undergo implantation with a monofocal/non-toric IOL
- Willing and able to comprehend informed consent and complete an 8-week visit.
- Potential postoperative Corrected Distance Visual Acuity (CDVA) of 20/20 or better in each eye based on Investigator's medical opinion
Key exclusion criteria (5 listed)
- Concurrent or prior ocular surgery within the previous 12 months.
- Ocular comorbidity that could reduce the potential postoperative CDVA based on the discretion of the operating surgeon
- History of hyperopic laser corneal refractive surgery
- History of radial keratotomy
- Irregular corneal astigmatism or keratoconus 6. Eyes with intraoperative or postoperative complications 7. Eyes with BCDVA worse than 20/100 preoperatively 8. Subjects who are pregnant or plan to become pregnant during the course of the study.
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 BiometerAlso: Swept Source Optical - Optical coherence tomography (SS-OCT)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. | Device | Study Participants |
Primary outcome
Refractive Outcomes
Time frame: 12 weeks
To evaluate refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.
Visual Outcomes
Time frame: 12 weeks
To evaluate visual in eyes with prior myopic refractive surgery undergoing cataract surgery using Sum-of-Segment biometry for IOL power calculations.
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 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
John Berdahl, MD principal investigator
Vance Thompson Vision Clinic Prof. LLC
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 Vance Thompson Vision 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 4 inclusion and 5 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 24 Aug 2025. 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?
Refractive Outcomes (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 24 Aug 2025.