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

Carl Zeiss Meditec

Status: Completed

Conditions: Cornea

Treatments: Device: Biometry

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03518775

IOLMaster 2017-01909

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

98 participants in 3 patient groups

Normal Eyes

Description:

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.

Treatment:

Device: Biometry

Cataract Eyes

Description:

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.

Treatment:

Device: Biometry

Post LVC Eyes

Description:

History of Laser Vision Correction (LVC)

Treatment:

Device: Biometry