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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-09

Study Completion Date

2025-02-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

NCT02842151

Cataract

COMPLETED NA

Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs

NCT05901597

Cataract

RECRUITING

Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION)

NCT06377007

Cataract

RECRUITING NA

Assessment of Visual Function and Optics in Intraocular Lenses

NCT01654159

Cataract

ENROLLING_BY_INVITATION NA

Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems

NCT01848288

Cataract

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational

No interventions will be administered.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No