Patient experience and satisfaction and clinical results after PanOptixToric IOL implantation in both eyes of patients undergoing cataract surgery

Not yet recruiting

Brief Summary: Aprospective, interventional, non-randomized, single centre study to to characterize the visual outcomes of PanOptixToric Multifocal IOLimplanted to replace the natural lens in cataract patients. Trial population shall comprise of adult Indian subjects 18-70 years ofage at the time of informed consent with no ocular pathology with regularcorneal topography and corneal astigmatism from 0.75 D to 4.00 D who requirecataract extraction. 33 subjects fulfilling the inclusion and exclusioncriteria undergoing bilateral implantation of PanOptixToric IOL implantation (n=66)following cataract surgery to be performed by a single surgeon at NethradhamaSuper Speciality Eye Hospital, will be included in the study to provide real world evidence on visual and refractive outcomes, and patientsatisfaction.

Recruitment & Eligibility

Inclusion Criteria

Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D.
Best Corrected Visual Acuity to be 0.2 LogMAR or lower 3.
Clear intraocular media 4.
Availability, willingness and sufficient cognitive awareness to comply with examination procedures.

Exclusion Criteria

Any active ocular disease 2.
Diabetic retinopathy, retinal degenerative disorders, macular degeneration, glaucoma with field defects 3.
Irregular corneal astigmatism( keratoconus/ PMD) 4.
Previous intraocular and corneal refractive surgery 5.
Pregnancy & Lactation 6.
Traumatic , Intumescent and white Cataracts 7.
Subject who have retinal pathologies or dystrophies and those who are expected to require retinal laser treatment 8.
Concurrent participation in another drug or device study.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: 3 Months post 2nd eye Surgery:-	Pre-opertative/ intra-opera visits and post-operative days 1, 15, 90, 180, 365
Corrected photopic distance visual acuity (CDVA, binocular)	Pre-opertative/ intra-opera visits and post-operative days 1, 15, 90, 180, 365

Secondary Outcome Measures

Name	Time	Method
1. Uncorrected and corrected photopic distance, intermediate and near visual acuity	2. Improvement in Quality of Life (Quality of Life Questionnaire developed by Rasch Analysis)

Locations (1): NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE
🇮🇳
Bangalore, KARNATAKA, India
NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE
🇮🇳Bangalore, KARNATAKA, India
DR SRI GANESH
Principal investigator
9845129740
phacomaverick@gmail.com