Comparison of vision following intraocular lens implantation using two different machines.
- Conditions
- Health Condition 1: H251- Age-related nuclear cataract
- Registration Number
- CTRI/2023/01/048676
- Lead Sponsor
- ENSAR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
â?? Healthy eyes besides age related cataract, aged between 40-80 years
â?? Eyes undergoing femtolaser assisted surgery with implantation of a hydrophobic monofocal toric IOL
â?? Regular corneal topography and corneal astigmatism within the range of 0.75D to 4.00D
â?? Availability, willingness, and sufficient cognitive awareness to
comply with examination procedures
â?? Signed informed consent
â?? Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation, and corneal endothelial cell insufficiency.
â?? Subjects with any systemic disease that could increase operative risk or confound the outcome
â?? Pregnant or lactating or planning a pregnancy at the time of enrolment
â?? Any patient who is taking part in another study involving ocular
surgery
â?? Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions)
â?? Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?? Post-op residual cylinder (D) <br/ ><br>â?? Manifest refraction (Sphere, Cylinder, Spherical Equivalent) <br/ ><br>â?? Uncorrected Distance Visual Acuity (UDVA) and Corrected Distance <br/ ><br>Visual Acuity (CDVA) using ETDRS charts at 4m <br/ ><br>â?? Rotational stability using dilated clinical examination and I-trace <br/ ><br>(Tracey technologies, Hoya, Japan). <br/ ><br>Timepoint: 1 WEEK, 1 MONTH, 3 MONTHS
- Secondary Outcome Measures
Name Time Method 1.Precision (Success/ Failure) of intra-operative image capture <br/ ><br>2.Intra-operative adverse events /post-op rotation/ re-surgery rateTimepoint: Intraoperative