Cataract surgery in eyes with a history of laser vision correction. IOL power for cataract surgery would be calculated using Zeiss IOLMaster 700 with total keratometry.
- Conditions
- Health Condition 1: H25- Age-related cataract
- Registration Number
- CTRI/2021/05/033483
- Lead Sponsor
- Carl Zeiss Meditec Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 <br/ ><br>1.Barrett True-K No history with Conventional Ks (keratometry) IOLMaster 700 <br/ ><br>2.Barrett True-K No history with Pentacam SimK (simulated keratometry) <br/ ><br>3.Haigis TK (total keratometry) with TK (total keratometry) IOLMaster 700 <br/ ><br>4.Haigis Lwith Conventional Ks IOLMaster 700 <br/ ><br>Timepoint: 6 weeks post-operatively