Health Condition 1: H25- Age-related cataract
Conditions
Interventions
Intervention1: IOLMaster 700 with Total Keratometry: The IOLMaster 700 with Total Keratometry (TK) is an optical biometer which provides information regarding the posterior corneal curvature. It also
Sponsors
Carl Zeiss Meditec Inc
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean prediction error (numerical and absolute), Proportion of eyes within 0.50/1.00 D of predicted post-op SE (spherical equivalent) for IOL power calculations with Barrett True-K No History with Measured posterior corneal astigmatism (IOLMaster 700 Total Keratometry).Timepoint: 6 weeks post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include mean prediction error (numerical and absolute), Proportion of eyes within 0.50/1.00 D of predicted post-op SE (spherical equivalent) for following additional IOL power calculation methods 1. Barrett True-K No history with Conventional Ks (keratometry) IOLMaster 700 2. Barrett True-K No history with Pentacam SimK (simulated keratometry) 3. Haigis TK (total keratometry) with TK (total keratometry) IOLMaster 700 4. Haigis L with Conventional Ks IOLMaster 700 Timepoint: 6 weeks post-operatively | — |
Countries
India
Contacts
Public ContactMansi Gupta
Carl Zeiss
Outcome results
None listed