Assessment of Measurement Variability Across Automated Biometry Devices

• Sponsor: Berkeley Eye Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06045325
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 4.2
• Patients Per Site Per Month: 47.2

Study Details

Study Description

Brief Summary

This is a non-interventional prospective, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Diagnostic Test: Orbscan II; Diagnostic Test: IOL Master 700; Diagnostic Test: IOL Master 500; Diagnostic Test: Atlas 9000; Diagnostic Test: Lenstar 900; Diagnostic Test: Pentacam; Diagnostic Test: iTrace; Diagnostic Test: Argos; Diagnostic Test: Manual caliper measurement

Detailed Description

This is a non-interventional prospective, single center, bilateral, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers. Additional biometric devices or external photography may be included as well.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Assessment of Measurement Variability Across Automated Biometry Devices
• Actual Study Start Date: Jul 25, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Myopic -1.00D Myopic patients with a diopter of at least -1.00

Diagnostic Test: Orbscan II; Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.; Diagnostic Test: IOL Master 700; Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.; Diagnostic Test: IOL Master 500; Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.; Diagnostic Test: Atlas 9000; Diagnostic assessment to measure white-to-white.; Diagnostic Test: Lenstar 900; Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.; Diagnostic Test: Pentacam; Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.; Diagnostic Test: iTrace; Diagnostic assessment to measure white-to-white and corneal thickness.; Diagnostic Test: Argos; Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.; Diagnostic Test: Manual caliper measurement; Manual diagnostic assessment to measure white-to-white.

Outcome Measures

Primary Outcome Measures

1. The correlation of white-to-white measurements between biometric devices. [Day of visit]

   The determination of the degree of correlation of white-to-white measurements between various biometric devices.

2. The correlation of anterior chamber depth measurements between biometric devices. [Day of visit]

   The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices.

3. The correlation of corneal thickness measurements between biometric devices. [Day of visit]

   The determination of the degree of correlation of corneal thickness measurements between various biometric devices.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Adults ages 18-50 years of age with healthy eyes and no prior ocular surgery

2. At least -1.00 of myopia (spherical equivalent)

3. Able to comprehend and willing to sign informed consent and consent and complete all required testing procedures

4. Clear intraocular media

Exclusion Criteria:

1. Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study

2. History of or current retinal conditions or predisposition to retinal conditions

3. Amblyopia or strabismus in either eye

4. History of or current anterior or posterior segment inflammation of any etiology

5. Any form of neovascularization on or within the eye

6. Glaucoma (uncontrolled or controlled with medication)

7. Optic nerve atrophy

8. Subjects with diagnosed degenerative eye disorders

9. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. connective tissue disease, immunocompromised, clinically significant atopic disease, etc.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Berkeley Eye Center	Houston	Texas	United States	77027

Sponsors and Collaborators

• Berkeley Eye Center

Investigators

• Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Berkeley Eye Center
• ClinicalTrials.gov Identifier: NCT06045325
• Other Study ID Numbers: BEC006
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Berkeley Eye Center: -1.00 Diopter Spherical Equivalent
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Sep 21, 2023