CataractNCT06801678
Refractive Outcomes Utilizing Two SS-OCT Biometers for IOL Power Calculations
An observational study of Cataract, run by The Eye institute of Utah at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the potential refractive outcomes using the Argos 1.5 biometer in the surgical planning for cataract extraction to that obtained from IOLMaster 700. Both devices are used as standard of care in surgical planning optimization for patients undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 22 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects at least 21 years of age, meeting inclusion and exclusion criteria.
Who may be able to join
- 21 years or older (Adult age)
- Assessed to have Cataract Grade 1 and above per LOCS III or Wisconsin Grading scale in at least one eye.
- Able to comprehend and sign the informed consent form.
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better and targeted post-op refraction to be emmetropia, based on the investigator expert medical opinion.
Who cannot join
- No active ocular infection or inflammation
- Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus)
- Contraindicated for pupil dilation (e.g., narrow angles, allergies) per medical judgement of the investigator.
- Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study result or may interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Lexi Guild, 801-263-5705, lguild@theeyeinstitute.com
Allison Hales, 8012635735, ahales@theeyeinstitute.com
About this study
The purpose of this study is to evaluate and compare the potential refractive outcomes using the Argos 1.5 biometer in the surgical planning for cataract extraction to that obtained from IOLMaster 700. Both devices are used as standard of care in surgical planning optimization for patients undergoing cataract surgery.
Read the detailed description
Cataract surgery is one of the most performed surgical procedures globally. The goal of the cataract surgeon is to implant an intraocular lens (IOL) with an appropriate IOL power to compensate for the refractive error and leave the patient emmetropic. The accurate measurement of ocular parameters is therefore critical for the effective calculation of IOL power, which directly impacts postoperative visual outcomes. However, accurate IOL power determination is influenced by several factors, including the measurement techniques employed and the specific biometers used in the process.
Optical biometry has become the gold standard for ocular measurements since the introduction of the IOLMaster (Carl Zeiss Meditec AG, Jena, Germany) in 2001. The IOLMaster 700 utilizes SWEPT Source OCT (SS-OCT) with a wavelength of about 1055 nm to generate a 2D OCT cornea-to-retina cross-section scan of the eye. This allows for the computation of all axial biometry measurements, including axial lengths (AL), central corneal thickness (CCT), anterior chamber depths (ACD), and lens thickness (LT).
A relatively newer biometer, Argos 1.5 is also non-invasive and based on SS-OCT technology for IOL power determination with a similar wavelength of 1060 nm ±10nm. However, the IOLMaster 700 uses a traditional axial length computation approach that relies on a single refractive index whiles Argos 1.5 uses a segmented axial length approach based on multiple refractive indices attributed to each ocular component often referred as True AL.
This study aims to evaluate and compare the potential refractive outcomes and biometric measurements of patients undergoing cataract surgery when using Argos 1.5 versus the IOLMaster 700 with the available formulas on each device. By analyzing these biometric measurements, we aim to uncover insights that could enhance our understanding of how different measurement techniques influence postoperative visual outcomes, ultimately contributing to improved patient care.
- Conditions
- Cataract
- Keywords
- Biometry, IOL Calculations, ARGOS, IOLM700, SS OCT Biometry
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | No interventions will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in predicted refraction
Predicted refraction is defined as the refractive power predicted by the IOL calculation formula. The predicted refraction for planned IOL power when using Argos 1.5 will be compared to IOL Master 700 for available formulae common to both devices (e.g. SRK/T, Barrett Universal II, Holladay I, Holladay II etc.) using forest plots. Data for Barrett TAL [Argos only] will be analysed using descriptive statistics
Measured: 1 month
Secondary outcomes (1)
Differences in the predicted IOL power for emmetropia
The differences in IOL predicted power will be compared using descriptive statistics and forest plots.
For the second endpoint, we will be comparing the biometry measurements (ACD, CCT, WTW, LT, AL, K readings) from both devices for the same subject eye. The agreement will be quantified using Bland-Altman analysis for each measure for the total subject population.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start9 Jan 2025
- Primary completion7 Feb 2025 (estimated)
- Study completion22 Feb 2025 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The Eye institute of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Zachary J Zavodni, MD, Principal investigator, The Eye institute of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801678
- Sponsor's protocol ID
- 12809-ZJZavodni
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Outcomes Utilizing Two SS-OCT Biometers for IOL Power Calculations
- ClinicalTrials.gov ID
- NCT06801678
- Acronym / sponsor ID
- 12809-ZJZavodni
- Conditions
- Cataract
- Keywords
- Biometry, IOL Calculations, ARGOS, IOLM700, SS OCT Biometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Eye institute of UtahUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 7 Feb 2025 (estimated)
- Study completion
- 22 Feb 2025 (estimated)
- First posted
- 30 Jan 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 purpose of this study is to evaluate and compare the potential refractive outcomes using the Argos 1.5 biometer in the surgical planning for cataract extraction to that obtained from IOLMaster 700. Both devices are used as standard of care in surgical planning optimization for patients undergoing cataract surgery.
Detailed description
Cataract surgery is one of the most performed surgical procedures globally. The goal of the cataract surgeon is to implant an intraocular lens (IOL) with an appropriate IOL power to compensate for the refractive error and leave the patient emmetropic. The accurate measurement of ocular parameters is therefore critical for the effective calculation of IOL power, which directly impacts postoperative visual outcomes. However, accurate IOL power determination is influenced by several factors, including the measurement techniques employed and the specific biometers used in the process.
Optical biometry has become the gold standard for ocular measurements since the introduction of the IOLMaster (Carl Zeiss Meditec AG, Jena, Germany) in 2001. The IOLMaster 700 utilizes SWEPT Source OCT (SS-OCT) with a wavelength of about 1055 nm to generate a 2D OCT cornea-to-retina cross-section scan of the eye. This allows for the computation of all axial biometry measurements, including axial lengths (AL), central corneal thickness (CCT), anterior chamber depths (ACD), and lens thickness (LT).
A relatively newer biometer, Argos 1.5 is also non-invasive and based on SS-OCT technology for IOL power determination with a similar wavelength of 1060 nm ±10nm. However, the IOLMaster 700 uses a traditional axial length computation approach that relies on a single refractive index whiles Argos 1.5 uses a segmented axial length approach based on multiple refractive indices attributed to each ocular component often referred as True AL.
This study aims to evaluate and compare the potential refractive outcomes and biometric measurements of patients undergoing cataract surgery when using Argos 1.5 versus the IOLMaster 700 with the available formulas on each device. By analyzing these biometric measurements, we aim to uncover insights that could enhance our understanding of how different measurement techniques influence postoperative visual outcomes, ultimately contributing to improved patient care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –No interventions will be administered. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects at least 21 years of age, meeting inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- 21 years or older (Adult age)
- Assessed to have Cataract Grade 1 and above per LOCS III or Wisconsin Grading scale in at least one eye.
- Able to comprehend and sign the informed consent form.
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better and targeted post-op refraction to be emmetropia, based on the investigator expert medical opinion.
Key exclusion criteria (4 listed)
- No active ocular infection or inflammation
- Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus)
- Contraindicated for pupil dilation (e.g., narrow angles, allergies) per medical judgement of the investigator.
- Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study result or may interfere significantly with the subject's participation in 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.
Primary outcome
Differences in predicted refraction
Time frame: 1 month
Predicted refraction is defined as the refractive power predicted by the IOL calculation formula. The predicted refraction for planned IOL power when using Argos 1.5 will be compared to IOL Master 700 for available formulae common to both devices (e.g. SRK/T, Barrett Universal II, Holladay I, Holladay II etc.) using forest plots. Data for Barrett TAL [Argos only] will be analysed using descriptive statistics
1 secondary outcome
Differences in the predicted IOL power for emmetropia
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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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.
Zachary J Zavodni, MD principal investigator
The Eye institute of Utah
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 The Eye institute of Utah 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 4 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: looking for participants now, as of the sponsor's last update on 30 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lexi L Guild (8012635705, lguild@theeyeinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in predicted refraction (time frame: 1 month). 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 30 Jan 2025.