CataractNCT05748275
Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
An observational study of Cataract, run by Multack Eye Care at 1 site in United States.
Trial summary
To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Argos and IOLMaster 700
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 15 Sep 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 85 years
- All sexes
- Adult, Older adult
Study population: Adults presenting with clinically significant cataracts.
Who may be able to join
- Age: 50-85 years old
- Clinically Significant Cataracts that interfere with daily activities
- Patient is able to understand and able to consent to informed consent
- Patient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 days
- Patient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.
Who cannot join
- Axial Length < 22.00 and > 26.00
- Corneal Astigmatism > +1.00 Diopters
- CCTS: < 490 and > 600
- Prior Refractive Surgery: RK, PRK, LASIK, INTACTS
- History of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgery
- Corneal Disease: Keratoconus, Corneal Dystrophies, Any prior corneal Surgery, Prior infections
Show all 16Show fewer
- Retinal Disease: Macular Pathology, CSCR, CME, Macular Degeneration, Drusen, Retinal Detachment, TPPV, SB, prior IVT, Prior PRP or Focal Laser, Diabetic Retinopathy
- History of Uveitis
- POAG: Undergoing any concomitant MIGS procedure- iStent, Omni, iTrack, Hydrus, etc
- Enrollment in any prior clinical trial within 2 years
- Systemic Disease that in the investigator's opinion may affect outcome
- Currently Pregnant or Breastfeeding
- Severe Dry Eye
- Tear Osmolarity > 320mOsms/L (Moderate)
- Any Surgical Complication(s)
- IOL implanted outside of the capsular bag /capsular damage /weakness /CTR placement
Trial locations and contacts
1 site in 1 country.
About this study
To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).
- Conditions
- Cataract
- Being tested
- Argos, 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.
ArgosDiagnostic test
Biometry measurements first with the Argos device, then the IOLMaster 700 device.
IOLMaster 700Diagnostic test
Biometry measurements first with the IOLMaster 700 device, then the Argos device.
| Study group | Role | What they receive |
|---|---|---|
| Argos, Then IOLMaster 700 | Biometry measurements first with the Argos device followed by the IOLMaster 700 device. Receives: Diagnostic Test: Argos; Diagnostic Test: IOLMaster 700 | |
| IOLMaster 700, Then Argos | Biometry measurements first with the IOLMaster 700 device followed by the Argos device. Receives: Diagnostic Test: Argos; Diagnostic Test: IOLMaster 700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Prediction Error (D)
Measured: 1 month postoperatively
Secondary outcomes (2)
Percentage of Eyes With Absolute Prediction Error 0.5 D or Less
Measured: 1 month postoperatively
Median Absolute Prediction Error (D)
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start19 Jul 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multack Eye Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Multack, D.O., Principal investigator, Multack Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748275
- Sponsor's protocol ID
- 64989743
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
- ClinicalTrials.gov ID
- NCT05748275
- Acronym / sponsor ID
- 64989743
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Multack Eye CareUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Argos, Then IOLMaster 700 | – | Diagnostic Test: Argos, Diagnostic Test: IOLMaster 700Biometry measurements first with the Argos device followed by the IOLMaster 700 device. |
| IOLMaster 700, Then Argos | – | Diagnostic Test: Argos, Diagnostic Test: IOLMaster 700Biometry measurements first with the IOLMaster 700 device followed by the Argos device. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults presenting with clinically significant cataracts.
Key inclusion criteria (5 listed)
- Age: 50-85 years old
- Clinically Significant Cataracts that interfere with daily activities
- Patient is able to understand and able to consent to informed consent
- Patient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 days
- Patient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.
Key exclusion criteria (16 listed)
- Axial Length < 22.00 and > 26.00
- Corneal Astigmatism > +1.00 Diopters
- CCTS: < 490 and > 600
- Prior Refractive Surgery: RK, PRK, LASIK, INTACTS
- History of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgery
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 |
|---|---|---|
| ArgosBiometry measurements first with the Argos device, then the IOLMaster 700 device. | Diagnostic test | Argos, Then IOLMaster 700, IOLMaster 700, Then Argos |
| IOLMaster 700Biometry measurements first with the IOLMaster 700 device, then the Argos device. | Diagnostic test | Argos, Then IOLMaster 700, IOLMaster 700, Then Argos |
Primary outcome
Mean Absolute Prediction Error (D)
Time frame: 1 month postoperatively
2 secondary outcomes
Percentage of Eyes With Absolute Prediction Error 0.5 D or Less
Time frame: 1 month postoperatively
Median Absolute Prediction Error (D)
Time frame: 1 month postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sam Multack, D.O. principal investigator
Multack Eye Care
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 Multack Eye Care 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 5 inclusion and 16 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 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Absolute Prediction Error (D) (time frame: 1 month postoperatively). 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 19 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.