NCT06801678 · The Eye institute of Utah
Refractive Outcomes Utilizing Two SS-OCT Biometers for IOL Power Calculations
What this study is about
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 the usual treatment in surgical planning optimization for patients undergoing cataract surgery.
View original scientific description
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Salt Lake City, Utah
Collaborators
Alcon Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2025 · Source of record for eligibility and locations