Repeatability and Reproducibility of the IOLMaster 700 Vers 1.70 and Agreement With IOLMaster 700 Vers. 1.50 and Pentacam
NCT ID: NCT03518775
Last Updated: 2018-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
98 participants
OBSERVATIONAL
2018-03-16
2018-04-20
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biometry
Measurement of Cornea
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.
Biometry
Measurement of Cornea
Post LVC Eyes
History of Laser Vision Correction (LVC)
Biometry
Measurement of Cornea
Interventions
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Biometry
Measurement of Cornea
Eligibility Criteria
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Inclusion Criteria
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
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).
22 Years
ALL
Yes
Sponsors
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ClinReg Consulting Services, Inc.
OTHER
Sierra Clinical Services, LLC
UNKNOWN
Carl Zeiss Meditec, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Slade, MD
Role: PRINCIPAL_INVESTIGATOR
Slade & Baker Vision
Locations
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Slade & Baker Vision
Houston, Texas, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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IOLMaster 2017-01909
Identifier Type: -
Identifier Source: org_study_id