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

NCT06377007 | Recruiting

• 1 other identifier: WU66290
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Cataract surgery represents a common surgical intervention, encompassing the extraction of the opaque natural crystalline lens, followed by the substitution with an artificial intraocular lens (IOL). To ascertain an IOL possessing optimal power, antecedent to the surgery, preoperative evaluations are conducted through the utilization of a biometric devices. Diverse categories of these instruments are accessible, each harnessing distinct optical methodologies or mathematical algorithms to ascertain the most fitting IOL power. The principal objective of this study was to evaluate the ocular biometry and the predictive precision outcome of a biometer that uses standard keratometry to the prediction accuracy of another biometer that uses Total Keratometry.

Conditions

Cataract

Keywords

Biometry; SS-OCT; IOLMaster700; Argos

Outcome Measures

Primary Outcomes (1)

• Mean absolute prediction error

  Mean absolute prediction error determining by the absolute disparity between the predicted spherical equivalent refraction derived from preoperative planning and the actual measured spherical equivalent refraction (manifest) from both devices (IOLMaster 700 and Argos)

  4 weeks

Secondary Outcomes (1)

• Proportion of eyes with an absolute prediction error equal to or less than 0.25

  4 weeks

Study Arms (2)

IOLMaster 700

ACTIVE COMPARATOR

IOLMaster 700 represents the gold standard for measuring ocular biometry before cataract surgery, employing a single refractive index.

Device: IOLMaster 700 (Carl Zeiss Meditec AG)

ARGOS

EXPERIMENTAL

ARGOS is a new device used to measure ocular biometry. It employs distinct refractive indices for different eye components such as the cornea, lens, and vitreous.

Device: Argos (Alcon Laboratories, Inc.)

Interventions

IOLMaster 700 (Carl Zeiss Meditec AG) DEVICE

Subjects will undergo measurements with the IOLMaster 700 device.

IOLMaster 700

Argos (Alcon Laboratories, Inc.) DEVICE

Subjects will undergo measurements with the Argos device.

ARGOS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cataract and/or presbyopia who will undergo intraocular lens implantation.

You may not qualify if:

• Central corneal thickness less than 490 mm or greater than 600 mm
• Contact lens use within 2 months of cataract surgery
• Severe dry eye
• Corneal or retinal disease affecting visual outcome
• Corneal astigmatism greater than 1.00 D
• Prior corneal refractive surgery
• Dense cataract that does not allow measurements to be taken with an optical biometrics system.

Sponsors & Collaborators

• Walailak University: lead

Study Sites (1)

Walailak University

Nakhon Si Thammarat, 80160, Thailand

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Jakkrit Juhong, MD.

CONTACT

0816773406; jakkrit.ju@wu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: April 22, 2024
• Study Start: January 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

TH (1)