Clinical outcomes after bilateral implantation of an Advanced Monofocal Intraocular Lens

Visual and functional outcomes after bilateral implantation of an Enhanced monofocal Intraocular Lens targeted for Mini-Monovision - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/083817

Enrollment

Registered

2025-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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: Phacoemulsification with bilateral implantation of an Extended Depth Of Focus intraocular lens: The Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) is an enhanced monofocal IOL

Eligibility

Inclusion criteria

Inclusion criteria: 1.Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts, Posterior subcapsular cataract 2. Age >35 years 3. Corneal astigmatism less than 0.75D 4. IOL power between +10D to +30D 5. In the bag IOL implantation

Exclusion criteria

Exclusion criteria: 1. Eyes with corneal astigmatism >0.75 D 2. Hypermature/morgagnian/intumescent and brunescent cataracts >NS 4 3. Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts 4. Pupillary abnormalities 5. History of glaucoma or intraocular inflammation 6. Macular disease or retinopathy, neuro-ophthalmic diseases, active infections, previous ocular surgery of any kind, any other ocular pathology. 7. Intraoperative or postoperative complications

Design outcomes

Primary

Measure	Time frame
Uncorrected Distant Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA) at 40, 60, 80cm and Uncorrected Near Visual AcuityTimepoint: Post operative Day 1, 2 weeks and 3 months	—

Secondary

Measure	Time frame
Contrast sensitivity, Objective scatter index, Defocus curves & AberrationsTimepoint: Post operative Day 1, 2 weeks & 3 months	—

Countries

India

Contacts

Public ContactAKANKSHA SHARMA

Nethradhama Superspeciality Eye Hopsital

nishikajain@gmail.com9712901438

Outcome results

None listed

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