Cataract and Corneal Abnormality
Conditions
Interventions
experimental group vs control group: ANTERION vs. other approved predicate devices
Sponsors
Heidelberg Engineering
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are able and willing to accept the trial process, give consent and follow instructions. 2. Subjects who have signed informed consent. 3. Subjects aged 18 years or above, male or female. 4. Subjects with one of the following eye conditions: (1) Eyes with normal anterior segment; (2) Cataractous eye; (3) Eyes with abnormal corneal morphology; (4) Postoperative ophthalmology after corneal refractive surgery; (5) The eye after cataract surgery.
Exclusion criteria
Exclusion criteria: 1. Vulnerable subjects (CGCP definition): pregnant women, mental retardation, patients in critical condition. 2. Subjects who have participated in other drug / medical device clinical trials that may affect this study in the past 3 months. 3. For subjects with severe dry eyes (determined by the researcher), any medical intervention or treatment such as PDT may lead to failure to cooperate or seriously affect the accuracy of image data. 4. Subjects who did not remove contact lenses at least 1 hour before imaging. 5. Subjects with the following ocular pathological states in each group: (1) Cataract, corneal abnormalities, corneal refractive surgery and / or after cataract surgery; (2) Corneal abnormalities, after corneal refractive surgery and / or cataract surgery; (3) After corneal refractive surgery and / or cataract surgery; (4) After cataract surgery; (5) No other ophthalmic abnormalities were found.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anterior segment parameters as Axial Length and Corneal Curvature; | — |
Countries
China
Contacts
Public ContactDr. Yu Ayong
Wenzhou Medical College
Outcome results
None listed