Refractive Outcomes Utilizing Two SS-OCT Biometers for IOL Power Calculations

NCT06801678 | Recruiting

• 1 other identifier: 12809-ZJZavodni
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

Biometry; IOL Calculations; ARGOS; IOLM700; SS OCT Biometry

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (1)

• Differences in the predicted IOL power for emmetropia

  1 month

Study Arms (1)

Observational

No interventions will be administered.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects at least 21 years of age, meeting inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Eye institute of Utah: lead
• Alcon Research: collaborator

Study Sites (1)

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Zachary J Zavodni, MD

  The Eye institute of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lexi L Guild

CONTACT

8012635705; lguild@theeyeinstitute.com

Allison Hales

CONTACT

8012635735; ahales@theeyeinstitute.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: January 9, 2025
• Primary Completion: February 7, 2025
• Study Completion: February 22, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

US (1)