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Clinical Study of Hydrophilic, Hydrophobic and PMMA intraocular lenses

Study to evaluate safety and performance of Hydrophilic, Hydrophobic and PMMA intraocular lenses

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038257
Enrollment
1020
Registered
2021-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: H590- Disorders of the eye following cataract surgery

Interventions

Intervention1: Implantation of Intraocular lens: Patients who had undergone cataract surgery with implantation of Intraocular lens will be selected for the study. Intervention2: Implantation of Intrao

Sponsors

Ophthalmic Marketing and Services Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Adult -Subjects who have already undergone cataract surgery using IOL -Calculated IOL power is within the range of the investigational IOL (+ 6.0 to 35.0 Diopter) -Subjects available after contact and willing to come for follow up during the clinical study. -Subjects with signed informed consent Subject having clear intraocular media other than cataract

Exclusion criteria

Exclusion criteria: - Patients unwilling to participate in the study - Subject with previous intraocular or corneal surgery - Subject having traumatic cataract - Pregnancy or lactation - Concurrent participation in another drug or device investigation - Instability of keratometry or biometry measurements - Irregular astigmatism

Design outcomes

Primary

MeasureTime frame
To assess the intraoperative Safety and Performance of the IOLTimepoint: one year

Secondary

MeasureTime frame
To determine the presence of lens related adverse events/residual risks and the visual acuity in the individuals on whom the device was implanted.Timepoint: 1 Year

Countries

India

Contacts

Public ContactMrNikhil

Tejas Eye Hospital

nikhilmehta1970@yahoo.in9979470241

Outcome results

None listed

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