Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06801678

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
The Eye institute of Utah · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

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

Timeline

Start date
2025-01-09
Primary completion
2025-02-07
Completion
2025-02-22
First posted
2025-01-30
Last updated
2025-01-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06801678. Inclusion in this directory is not an endorsement.