Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: TECHNIS EYHANCE IOL: IT IS AN INTRAOCULAR LENS INSERTED IN THE EYE AT THE TIME OF CATARACT SURGERY
Control Intervention1: EYECRYL SERT IOL: IT IS AN INTRAOCULAR LENS INSERTED IN THE EYE
Sponsors
BIOTECH VISION CARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1)Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse with significant cataract-related visual symptoms. 2)Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation. 3) 4)Clear intraocular media other than cataract. 5)Given written informed consent by subject. 6)Subjects are willing and able to comply with schedule for follow-up visits. 7)Subjects should be 22 years or older.
Exclusion criteria
Exclusion criteria: 1)Systemic disease that could increase the operative risk or confound the outcome. 2)Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome). 3)Ocular condition that may predispose for future complications. 4)Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject. 5)Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes. 6)Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse. 7)Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens. 8)If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) UDVA 2) CDVA 3) UIVA 4) DCIVA AT 60 AND 80 CM 5) MANIFEST REFRACTION 6) UNVA 7) DCIVA AT 40CM 8) LENS STABILITY 9) PUPIL SIZETimepoint: 2 WEEKS POST OPERATIVE PERIOD | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) BINOCULAR CORRECTED DEFOCUS CURVE 2) DISTANCE CORRECTED AND BEST CORRECTED LOW CONTRAST ( 10%) 3) SRD 4) LENS STABILITY 5) PUPIL SIZE 6) CSV 1000 7) PCO RATE 8) SUBJECTIVE QUESTIONAIRRETimepoint: 6 MONTHS POST OPERATIVE PERIOD | — |
Countries
India
Contacts
Public ContactDR KRUPALI DEEPAK SHETH
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL
Outcome results
None listed