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To Study the Safety and Performance of Cast molded, Preloaded Hydrophobic Intraocular lenses (IOL) in age-related Cataract patients

Evaluation of Safety and visual Performance of Cast molded, Preloaded Hydrophobic Intraocular lenses (IOL) in age-related Cataract patients - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085465
Enrollment
105
Registered
2025-04-23
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: H259- Unspecified age-related cataract

Interventions

Intervention1: Cast molded Hydrophobic IOL: -Cast molded Hydrophobic IOL will be implanted in 102 eyes of 88 patients -The patients will be followed up for 1 day 1 week 1 month 6 month and 1 year -The

Sponsors

Aurolab
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Senile cataract eligible for phaco emulsification cataract surgery 2 Clear intraocular media other than cataract 3 Age above 40 years 4 BCVA equal to less than 6/12 in the study eye 5 Pre operative corneal astigmatism less than one diopter 6 Able to read understand and provide informed consent

Exclusion criteria

Exclusion criteria: 1 Uncontrolled Diabetic retinopathy or systemic hypertension or cardiac disorder 2 Pseudo exfoliation 3 Traumatic cataract 4 Small pupil 5 Any pre existing corneal pathologies or dry eyes 6 Post lasik or refractive surgeries 7 Uncontrolled glaucoma or on treatment for glaucoma in either eye 8 Preoperative retinal detachment or clinically significant retinal pathology in the operative eye 9 Congenital cataracts 10 Prior ocular surgery in the study eye

Design outcomes

Primary

MeasureTime frame
-Best Uncorrected Distance Visual Acuity Timepoint: - 1 day - 1 week - 1 month - 6 months - 1 year

Secondary

MeasureTime frame
-Incidence of PCO formation -Glistening of IOLTimepoint: - 1 day - 1 week - 1 month - 3 month - 6 months - 1 year

Countries

India

Contacts

Public ContactDr MadhuShekhar

Aravind Eye Hospital Madurai

madhushekhardr@aravind.org04524356105

Outcome results

None listed

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