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A post-marketing study to check the safety and performance of Eyecryl Plus lens used during cataract surgery

Prospective, single arm, post-marketing clinical study of Eyecryl plus multi piece Monofocal Hydrophilic Acrylic Foldable Intraocular Lens to assess performance and safety in patients undergoing cataract surgery. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/106751
Enrollment
173
Registered
2026-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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: Eyecryl plus multi piece Monofocal hydrophilic intraocular lenses (IOL): Eyecryl plus multi piece Monofocal hydrophilic intraocular lenses (IOL) are acrylic foldable three-piece posteri

Sponsors

Biotech Vision Care Pvt Itd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 year or greater 2. Cataract 3. Calculated IOL power is within the range of the Study IOL. 4. Clear intraocular media other than cataract 5. Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose 6. Patient willing to come for all post-operative follow-up 7. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study

Exclusion criteria

Exclusion criteria: 1. Previous intraocular or corneal surgery 2. Traumatic cataract 3. Pregnancy 4. Concurrent participation or participation in the last 30 days in any other clinical trial 5. Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy) 6. Gonioscopic abnormalities 7. Irregular astigmatism. 8. Instability of keratometry or biometry measurements. 9. History of intraocular inflammation. 10. Vulnerable subject.

Design outcomes

Primary

MeasureTime frame
Percentage of subject achieving distance uncorrected visual acuity within (0.2 logMAR or better) at 180 days post operatively.Timepoint: Post operative 1 day, 7 day, 1 month and 6 months

Secondary

MeasureTime frame
Percentage of subject achieving distance Best spectacle corrected visual acuity within (0.2 logMAR or better) at 180 days post operatively.Timepoint: Post operative 7 day, 1 month

Countries

India

Contacts

Public ContactMR BHARGAV JOSHI

BIOTECH VISION CARE PVT LTD

bhargav.joshi@biotechhealthcare.com09925925667

Outcome results

None listed

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