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| Name | Class |
|---|---|
| ClinReg Consulting Services, Inc. | OTHER |
| Sierra Clinical Services, LLC | UNKNOWN |
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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):
Specific Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| Post LVC Eyes | History of Laser Vision Correction (LVC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biometry | Device | Measurement of Cornea |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Slade, MD | Slade & Baker Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slade & Baker Vision | Houston | Texas | 77027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11738911 | Background | 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. | |
| 27838682 | 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. |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001699 | Biometry |
| ID | Term |
|---|---|
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D015991 | Epidemiologic Measurements |
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| 15030827 | 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. |
| D011634 | Public Health |
| D004778 | Environment and Public Health |