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Safety and Efficacy of a New Enhanced Monofocal Intraocular Lens

Evaluation of Visual Outcomes and Quality of Vision following Implantation of a New Enhanced Monofocal Intraocular Lens - Nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067844
Enrollment
60
Registered
2024-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: H259- Unspecified age-related cataract

Interventions

Intervention1: Intraocular Lens Implantation: Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) is a single-piece enhanced monofocal IOL crafted from glistening-free hydrophobic acrylate. After

Sponsors

Nethradhama Super Speciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts, Posterior subcapsular cataract Corneal astigmatism equal to or less than 1D IOL power between +10D to +30D In the bag IOL implantation

Exclusion criteria

Exclusion criteria: Eyes with corneal astigmatism more than 1.0 D Hypermature/morgagnian/intumescent and brunescent cataracts more than NS 4 Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts less than 1500 Pupillary abnormalities History of glaucoma or intraocular inflammation Macular disease or retinopathy, neuro-ophthalmic diseases, active infections, previous ocular surgery of any kind, any other ocular pathology. Intraoperative or postoperative complications

Design outcomes

Primary

MeasureTime frame
To evaluate distance, intermediate and near visual acuity after implantation of Vivinex Impress XY-IM100 (Hoya Surgicals) for age related cataracts.Timepoint: Baseline, Post operative day 1, 15 and 3 months

Secondary

MeasureTime frame
To evaluate quality of vision by measuring contrast sensitivity, objective scatter index, spherical aberrations, and defocus curve.Timepoint: post operative day 1, 15 and 3 months

Countries

India

Contacts

Public ContactKaranam Dhatri

Nethradhama Super Speciality Eye Hospital

k.dhatri90@gmail.com9052188216

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026