Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam

NCT03518775 | Completed FDA Device

• 1 other identifier: IOLMaster 2017-01909
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to determine the agreement of measurements between the IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 and Pentacam, as well as to evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers 1.70. The following parameters will be evaluated for Total Keratometry, (TK) and Posterior Corneal Surface (PCS):

• cylinder (CYL), Axis (A)
• spherical equivalent (SE) Specific Objectives:
• To compare the agreement of SE between IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 (Carl Zeiss Meditec AG, Jena, Germany)
• To compare the agreement of Cylinder magnitude and axis between IOLMaster 700 SW Version 1.70 and Pentacam
• To evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers. 1.70 for all measurement parameters listed above

Conditions

Cornea

Outcome Measures

Primary Outcomes (3)

• Measurement Agreement between IOL Master Software Versions 1.70 and 1.50.

  IOLMaster 700 Vers. 1.70 SE\_TK (Spherical Equivalent\_Total Keratometry) Measurements will be compared to IOLMaster 700 SW Vers. 1.50 SE\_K (Spherical Equivalent\_Keratometry) Measurements for Agreement.

  1 hour

• Measurement Agreement between IOLMaster Software Version 1.70 and Pentacam.

  IOLMaster 700 Vers. 1.70 A\_TK (Axis\_Total Keratometry), Cyl\_TK (Cylinder\_Total Keratometry), A\_PCS (Axis\_Posterior Corneal Surface), SE\_PCS (Spherical Equivalent\_Posterior Corneal Surface), and Cyl\_PCS (Cylinder\_Posterior Corneal Surface) Measurements will be compared to Pentacam Measurements for Agreement.

  1 hour

• Repeatability and Reproducibility of IOLMaster 700 Software Version 700 Measurements.

  3\. Evaluate the Repeatability and Reproducibility of the IOLMaster 700 SW Version 1.70 for A\_TK, A\_PCS, Cyl\_TK, Cyl\_PCS, SE\_TK and SE\_PCS.

  1 hour

Study Arms (3)

Normal Eyes

Eyes with best-corrected visual acuity of 20/20 or better, and lens opacities of 1.0 or less in the study eye using the LOCS III system, and no prior Laser Vision Correction.

Device: Biometry

Cataract Eyes

Cataract in the study eye greater than Grade 1 using the LOCS III system for one or more: nuclear opacity, nuclear color, cortical opacity, or PSC.

Device: Biometry

Post LVC Eyes

History of Laser Vision Correction (LVC)

Device: Biometry

Interventions

Biometry DEVICE

Measurement of Cornea

Cataract Eyes; Normal Eyes; Post LVC Eyes

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There will be three cohorts: normal eyes (Group 1), cataract eyes (Group 2), and post Laser Vision Correction (LVC) eyes (Group 3), with no cross-over between the study groups.

You may qualify if:

• Male or Female 22 years of age and older.
• No history of rigid contact lens wear for at least 2 weeks. Soft lenses, if worn, should be removed at least one hour prior to the measurement.
• Able and willing to make the required study visits.
• Able and willing to give consent and follow study instructions.
• Group 1: normal eyes with best-corrected visual acuity of 20/20 or better, and lens opacities of 1.0 or less in the study eye using the LOCS III system, and no prior Laser Vision Correction.
• Group 2: cataract in the study eye greater than Grade 1 using the LOCS III system for one or more: nuclear opacity, nuclear color, cortical opacity, or PSC.
• Group 3: history of Laser Vision Correction (LVC).

You may not qualify if:

• Previous intraocular surgery other than Laser Vision Correction in the study eye.
• Previous corneal surgery other than Laser Vision Correction in the study eye.
• Presence of any corneal or retinal abnormality on slit lamp examination in the study eye.
• Corneal Cylinder \< 0.75D measured with a IOLMaster.
• Active ocular infection or inflammation.
• Poor tear film/insufficient corneal reflex.
• Best corrected visual acuity worse than 20/200 in the study eye.
• Physical inability to be positioned at the slit-lamp biomicroscope or study devices (e.g. torticollis, head tremor, etc.).
• Insufficient eyelid opening or eyelashes which partially conceal alignment or keratometry reflections and prevent capture of all measurements.
• Inability to fixate (e.g. due to nystagmus, amblyopia or ocular disease, such as macular degeneration).
• Rigid contact lens wear during past two weeks.
• Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRFs).

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead
• ClinReg Consulting Services, Inc.: collaborator
• Sierra Clinical Services, LLC: collaborator

Study Sites (1)

Slade & Baker Vision

Houston, Texas, 77027, United States

Location

Related Publications (3)

• Vogel A, Dick HB, Krummenauer F. Reproducibility of optical biometry using partial coherence interferometry : intraobserver and interobserver reliability. J Cataract Refract Surg. 2001 Dec;27(12):1961-8. doi: 10.1016/s0886-3350(01)01214-7.

  PMID: 11738911 BACKGROUND

• Lu MJ, Zhong WH, Liu YX, Miao HZ, Li YC, Ji MH. Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method. Int J Biostat. 2016 Nov 1;12(2):/j/ijb.2016.12.issue-2/ijb-2015-0039/ijb-2015-0039.xml. doi: 10.1515/ijb-2015-0039.

  PMID: 27838682 BACKGROUND

• Baumeister M, Terzi E, Ekici Y, Kohnen T. Comparison of manual and automated methods to determine horizontal corneal diameter. J Cataract Refract Surg. 2004 Feb;30(2):374-80. doi: 10.1016/j.jcrs.2003.06.004.

  PMID: 15030827 BACKGROUND

MeSH Terms

Conditions

Corneal Diseases

Interventions

Biometry

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Stephen Slade, MD

  Slade & Baker Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: May 8, 2018
• Study Start: March 16, 2018
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)