CTRI/2021/05/033483
Active, not recruiting
Phase 4
Evaluation of cataract refractive outcomes in eyes with a history of laser vision correction using Zeiss IOLMaster 700 with total keratometry.
Carl Zeiss Meditec Inc0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: H25- Age-related cataract
- Sponsor
- Carl Zeiss Meditec Inc
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent for participation in the study and data protection. 2\. Male or female, age 22 years or older at the time of study enrollment. 3\. Projected postoperative best corrected distance visual acuity (BCDVA) 0\.20 logMAR or better in the study eye, as determined by Investigatorâ??s medical judgment. 4\. Consecutive patients undergoing planned cataract surgery for a visually significant cataract with astigmatism of \<\= 1\.00 D in whom the eye passes the image quality metrics on both machines. 5\. Patients undergoing implantation of single piece acrylic monofocal IOL (intraocular lens) after cataract surgery. 6\. Patients who had previous myopic laser vision correction surgery (Laser in\-situ keratomileusis, Laser Assisted Sub\-Epithelial Keratectomy, Photorefractive keratectomy) and now undergoing surgery for cataract. 7\. No visual acuity limiting pathologies, at the discretion of the operating surgeon. 8\. Availability, willingness and sufficient cognitive awareness to comply with examination procedures.
Exclusion Criteria
- •1\.Previous ocular surgery (non\-refractive), acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeonâ??s opinion, confound results (e.g., corneal pathology, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.).
- •2\.Soft contact lens usage during the previous month
- •3\.Rigid gas permeable contact lens wearer within the previous 2 months
- •4\.Pupil abnormalities (non\-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3\.5 mm).
- •5\.Biometry measurements that cannot be captured.
- •6\.Expected visual potential of worse than 0\.2 logMAR (20/30 or 6/9\.5\) due to ocular pathologies, e.g., retinal disorders.
- •7\.Patients who had previously undergone SMILE (Small Incision Lenticule Extraction)
- •8\.Pregnant or lactating females
Outcomes
Primary Outcomes
Not specified
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