Clinical trial NCT03518775: Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam
Official title: Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cornea
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ClinReg Consulting Services, Inc.
name: Sierra Clinical Services, LLC
First posted: 2018-05-08
Enrollment: 98
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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:

1. 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)
2. To compare the agreement of Cylinder magnitude and axis between IOLMaster 700 SW Version 1.70 and Pentacam
3. To evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers. 1.70 for all measurement parameters listed above


Eligibility criteria: Inclusion Criteria:

1. Male or Female 22 years of age and older.
2. 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.
3. Able and willing to make the required study visits.
4. Able and willing to give consent and follow study instructions.
5. 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.
6. 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.
7. Group 3: history of Laser Vision Correction (LVC).

Exclusion Criteria:

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

Primary outcomes:
measure: Measurement Agreement between IOL Master Software Versions 1.70 and 1.50.
timeFrame: 1 hour
measure: Measurement Agreement between IOLMaster Software Version 1.70 and Pentacam.
timeFrame: 1 hour
measure: Repeatability and Reproducibility of IOLMaster 700 Software Version 700 Measurements.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Slade & Baker Vision
state: Texas
Study officials:
affiliation: Slade & Baker Vision
name: Stephen Slade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.