Health Condition 1: H251- Age-related nuclear cataract
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex, aged between 40- 75 years diagnosed with nuclear or cortico-nuclear cataract of grade I- IV according to the Lens Opacity Classification System III (LOCS III) scale Suitable to undergo phacoemulsification with foldable Intraocular Lens (IOL) implantation within an IOL power range of +16 to +24 D Willing and able to understand/sign a written informed consent document
Exclusion criteria
Exclusion criteria: LOCS-III Nuclear sclerosis grade 4+ Complex cases of cataract such as mature and intumescent, morgagnian, posterior polar, phacomorphic glaucoma, uveitic cataracts, traumatic and subluxated cataracts Poorly dilating pupils or patients on alpha adrenergic antagonists for benign prostrate hyperplasia (BPH) requiring pupil expansion devices intra-operatively Corneal diseases such as keratoconus, pellucid marginal degeneration, leucomatous corneal scars, corneal degenerations Planned multiple procedures at the time of surgery or during the course of the study (e.g., LASIK, LRI, etc.) Previous intraocular or corneal surgery of any kind Severe optic nerve and retinal disorders (e.g., glaucomatous cupping, optic atrophy, macular degeneration, proliferative diabetic retinopathy, retinal detachment) Immunocompromised or systemic conditions which may increase the operative risk or confound the result of this investigation Female patients who are pregnant or lactating Currently participating in another drug or device clinical trial Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)repeatability 2)satisfaction grading score of the surgeon will be measured Timepoint: baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| statical analysisTimepoint: 1 day | — |
Countries
India
Contacts
Nethradhama Superspeciality Eye Hospital