CTRI/2021/12/038930
Not yet recruiting
Phase 4
A prospective, randomized clinical study of two phakictoric implantablelenses to outcome in in patients with moderate to high myopia and astimatism.
Biotech Healthcare Holdings GmbH0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biotech Healthcare Holdings GmbH
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients 21 years old or older.
- •2\. Calculated IOL Power is within the range of the investigational IOLs
- •3\. Corneal Cylindrical error within the range defined in the clinical investigation plan
- •4\. Subject has monocular UCVA 0\.5 LogMAR or worse
- •5\. Subject has had a stable refraction (±0\.5D; ±1\.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
- •6\. Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0\.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria:
- •a. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
- •b. Two refractions were performed at least 7 days apart.
- •7\. Subject, who is expected to have residual postoperative cylindrical refractive error of \>\=1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
- •8\. Expected dilated pupil size at least large enough to visualize the axis marking.
Exclusion Criteria
- •1\. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
- •2\. Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
- •3\. Subject with ocular condition that may predispose the subject to future complications
- •4\. Subject with previous intraocular or corneal surgery
- •5\. Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
- •6\. Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
- •7\. Other condition associated with fluctuation of hormones
- •8\. ACD measured from the endothelium lower than 2\.8 mm
- •9\. Concurrent participation in another drug or device evaluation.
- •10\. Any cataract of any grade
Outcomes
Primary Outcomes
Not specified
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