Assessment of Measurement Variability Across Automated Biometry Devices

Myopia Clinical Trial

Official title:

Assessment of Measurement Variability Across Automated Biometry Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06045325
• Other study ID #: BEC006
• Status: Completed
• Start date: July 25, 2023
• Est. completion date: February 16, 2024

Study information

• Verified date: April 2024
• Source: Berkeley Eye Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
United States	Berkeley Eye Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Berkeley Eye Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of white-to-white measurements between biometric devices.	The determination of the degree of correlation of white-to-white measurements between various biometric devices.	Day of visit
Primary	The correlation of anterior chamber depth measurements between biometric devices.	The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices.	Day of visit
Primary	The correlation of corneal thickness measurements between biometric devices.	The determination of the degree of correlation of corneal thickness measurements between various biometric devices.	Day of visit