A clinical study of EYECRYL™ PLUS (600) intraocular lens in patients undergoing cataract surgery.

Prospective, single arm, post-marketing clinical study of EYECRYL™ PLUS (600) intraocular lens to assess performance and safety in patients undergoing cataract surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044819

Enrollment

850

Registered

2022-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: EYECRYL™ PLUS (600), Monofocal Hydrophillic Acrylic Foldable Intraocular Lens.: Eyecryl hydrophilic intraocular lenses (IOL) are acrylic foldable single piece & multi-piece posterior ch

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 year or greater 2. Cataract 3. Calculated IOL power is within the range of the study IOLs. 4. Given consent to use device related data for scientific purpose 5. Clear intraocular media other than cataract 6. Patient willing to participate and sign informed consent 7. Patient willing to come for all post-operative follow-up 8. 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. Irregular astigmatism 6. Instability of keratometry or biometry measurements 7. Vulnerable subject. 8. Patients receiving chloroquine treatment. 9. Patient having Microphthalmia. 10. Patient having Chronic Uveitis. 11. Patient suffering from corneal dystrophy or endothelial insufficiency. 12. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma)

Design outcomes

Primary

Measure	Time frame
Percentage of eyes that will achieve distance uncorrected visual acuity within (0.3 logMAR or better) at 180 days post operatively.Timepoint: Percentage of eyes that will achieve distance uncorrected visual acuity within (0.3 logMAR or better) at 180 days post operatively.	—

Secondary

Measure	Time frame
To assess safety of EYECRYL™ PLUS 600 intraocular lens in patients undergoing cataract surgery.Timepoint: Time frame: Preoperative, 7-14 days, 30-60 days, 120-180 days, 330-420 days, 630-780 days and 990-1140 days post operatively.	—

Countries

India

Contacts

Public ContactProf A Heber

Dr. Agarwals Eye Hospital

drlionalraj@dragarwal.com8754411261

Outcome results

None listed

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