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Comparison of vision following intraocular lens implantation using two different machines.

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
1.Precision (Success/ Failure) of intra-operative image capture <br/ ><br>2.Intra-operative adverse events /post-op rotation/ re-surgery rateTimepoint: Intraoperative
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