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

NCT ID: NCT06377007

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-30

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.

Detailed Description

Two swept-source optical coherence tomography (SS-OCT) biometers, namely the Argos and the IOLMaster 700, will be employed for the preoperative assessment of the eyes of all subjects who will undergo cataract surgery at the Eye Outpatient Department (OPD) of Walailak University Hospital. The sequence of biometry measurements will be randomized among the subjects. In Group 1, measurements will be initially conducted using the Argos device, followed by the IOLMaster 700 device. Conversely, Group 2 subjects will undergo measurements with the IOLMaster 700 device first, followed by the Argos device. The sequence will be continuous without any breaks. The analysis will encompass the right eyes of each subject.

For the purpose of preoperative planning, the Argos device will utilize the Barrett Universal Formula II "K," whereas the IOLMaster 700 device will employ the Barrett Universal II TK formula. The objective for all eyes will be to achieve a plano outcome. In instances where the suggested intraocular lens (IOL) power differs between the two biometers, the IOL power recommended by the IOLMaster 700 device will be selected. Cataract surgeries will be exclusively performed by a seasoned surgeon (SM), who will adhere to a consistent approach involving a clear temporal incision (2.75 mm) followed by manual capsulorhexis. Refractive and visual outcomes will be evaluated within a postoperative timeframe of 28 to 42 days. Subjective refractions will be conducted by an optometrist, ensuring blinding to the biometry data.

The primary endpoint of this study will be the mean absolute prediction error exhibited by each SS-OCT biometer. The computation of the absolute prediction error will involve determining the absolute disparity between the predicted spherical equivalent refraction derived from preoperative planning and the actual measured spherical equivalent refraction (manifest). Secondary objectives will encompass the median absolute prediction error and the proportion of eyes with an absolute prediction error equal to or less than 0.25 D and 0.5 D.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

IOLMaster 700

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

Group Type: ACTIVE_COMPARATOR

IOLMaster 700 (Carl Zeiss Meditec AG)

Intervention Type: DEVICE

Subjects will undergo measurements with the IOLMaster 700 device.

ARGOS

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.

Group Type: EXPERIMENTAL

Argos (Alcon Laboratories, Inc.)

Intervention Type: DEVICE

Subjects will undergo measurements with the Argos device.

Interventions

IOLMaster 700 (Carl Zeiss Meditec AG)

Subjects will undergo measurements with the IOLMaster 700 device.

Intervention Type: DEVICE

Argos (Alcon Laboratories, Inc.)

Subjects will undergo measurements with the Argos device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walailak University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Walailak University

Nakhon Si Thammarat, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Jakkrit Juhong, MD.

Role: CONTACT

jakkrit.ju@wu.ac.th

0816773406

Facility Contacts

Jakkrit.ju Juhong, MD.

Role: primary

jakkrit.ju@wu.ac.th

0816773406

Other Identifiers

WU66290

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

WU66290

Identifier Type: -

Identifier Source: org_study_id