Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Intervention1: OPTIFLEX TRIO (Hydrophobic Aspheric Foldable IOL): This lenses are designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. It is manufact
Sponsors
Biotech Healthcare Holdings GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age of patient >21 years 2.Patient diagnosed with cataract 3.Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5D as per corneal topography or keratometry 4.Calculated IOL Power is within the range of the investigational IOLs 5.Patient willing to sing informed consent form 6.Clear intraocular media other than cataract 7.Female participants of child bearing potential must be willing to ensure that they use effective contraception during the study
Exclusion criteria
Exclusion criteria: 1.Previous intraocular or corneal surgery 2.Traumatic Cataract. 3.Pregnancy (as stated by patient) or lactation 4.Concurrent participation in another drug or device investigation 5.Irregular Astigmatism 6.Patient receiving chlorquine treatment 7.Subjects with any systemic disease that could increase operative risk or confound the outcome 8.Active ocular disease in the operative eye other than cataract 9.Vulnerable subjects 10.Corneal Astigmatism >4.5D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lensesTimepoint: ➢ Post-operative 1 Day ➢ Post-operative 1 Week Ã?± 2 Days ➢ Post-operative 1 Month Ã?± 7 Days ➢ Post-operative 3 Months Ã?± 7 Days ➢ Post-operative 6 Months Ã?± 14 Days ➢ Post-operative 12 Months Ã?± 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess and compare the safety of two trifocal toric intraocular lensesTimepoint: ➢ Post-operative 1 Day ➢ Post-operative 1 Week Ã?± 2 Days ➢ Post-operative 1 Month Ã?± 7 Days ➢ Post-operative 3 Months Ã?± 7 Days ➢ Post-operative 6 Months Ã?± 14 Days ➢ Post-operative 12 Months Ã?± 30 Days | — |
Countries
Germany, India
Contacts
Public ContactMr Devendrapalsingh Khalsa
BIOTECH VISION CARE PVT. LTD
Outcome results
None listed