Health Condition 1: null- Normal Cornea subjects, Post-LASIK Subjects and Subjects with Corneal Pathology
Conditions
Sponsors
Carl Zeiss India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Group A: For inclusion, as Normal Cornea subjects, both eyes (OD & OS) must fulfil all of the following criteria 1. Males or females 18 years of age or older who had normal corneas 2. Able and willing to make the required study visits 3. Able and willing to give consent and follow study instructions Group B: Post-LASIK subjects (any eye OD or OS must meet the criteria) 1. Males or females 18 years of age or older, who had undergone uncomplicated LASIK surgery for either myopia or hyperopia within 2-24 weeks 2. Able and willing to make the required study visits 3. Able and willing to give consent and follow study instructions Group C: Subjects with Corneal Pathology (any eye, OD or OS must meet the criteria) 1. Males or females 18 years of age or older, with a pathological diagnosis in the anterior segment that involved or affected the cornea. Such diagnosis could include but not limited to: keratoconus, pellucid marginal degeneration, corneal scarring, corneal degeneration, corneal dystrophy and corneal changes secondary to disease or surgery 2. Able and willing to make the required study visits 3. Able and willing to give consent and follow study instructions
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Unable to understand and follow the instructions on study procedures 2. Unable to cooperate for study procedures, specifically in terms of fixation 3. Unable to sit upright in front of the device 4. Presence of tremor, pathological rotational nystagmus and dyspnea 5. Any active infection of anterior or posterior segments 6. Unable to return for the required study visits Group A Normal Cornea subjects 1. Subjects who had undergone prior surgery or a procedure involving or affecting the cornea in the study eye 2. Presence of corneal pathology, either inflammatory or non-inflammatory, in the study eye 3. Blindness, low vision and/or severely diseased eyes 4. History of leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis Group B: Post LASIK subjects 1. Subjects who had undergone prior refractive and corneal surgery, except LASIK, in the study eye 2. Subjects who had LASIK less than 2 weeks or more than 24 weeks prior to the day of data collection 3. Presence of corneal pathology, either inflammatory or non-inflammatory, in the study eye 4. History of complicated LASIK surgery necessitating re-treatment and enhancements 5. Blindness, low vision and/or severely diseased eyes 6. History of leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis Group C: Subjects with Corneal Pathology 1. Subjects with normal corneas in the study eye 2. Subjects who had undergone LASIK in the study eye 3. Blindness or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images.History of leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the repeatability and reproducibility of PRIMUS 300 Pachymetry measurementTimepoint: 4 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare Pachymetry measurements of PRIMUS 300 to the corresponding CIRRUS 400 Pachymetry measurementsTimepoint: 4 Months | — |
Countries
India
Contacts
Public ContactMr Ravi Rajhans
Carl Zeiss India (Bangalore) Pvt Ltd
Outcome results
None listed