Comparison of two types of intraocular lenses meant for providing both distance and near vision after cataract surgery

Comparison of clinical outcomes and patient satisfaction of two Hydrophobic EDOF Toric intraocular lenses following bilateral implantation. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060492

Enrollment

Registered

2023-12-04

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: H259- Unspecified age-related cataract

Interventions

Intervention1: INTRAOCULAR LENS IMPLANTATION POST CATARACT SURGERY: EDOF Toric lens Eyecryl Sert (Preloaded Hydrophobic EDOF Toric Lens) (Biotech Vision Care Pvt Itd, Ahmedabad, India) Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms. 2. Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation as estimated by potential acuity meter (PAM) or surgeon estimation 3. Clear intraocular media other than cataract. 4. Given written informed consent by subject. 5. Subjects are willing and able to comply with schedule for follow up visits. 6. Subjects should be 22 years or older.

Exclusion criteria

Exclusion criteria: 1. Systemic disease that could increase the operative risk or confound the outcome. 2. Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)). 3. Ocular condition that may predispose for future complications. 4. Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.

Design outcomes

Primary

Measure	Time frame
Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditionsTimepoint: Pre-operative, 1-2days, 7-14 days, 30-60 days, 120-180 days, 330- 420 days]	—

Secondary

Measure	Time frame
1) Uncorrected distance visual acuity (UCDVA) [photopic] 2) Uncorrected intermediate visual acuity (UCIVA) [photopic] 3) Best corrected distance visual acuity (BCDVA) [photopic] 4) Uncorrected Near visual acuity (UCNVA) [photopic] 5) Distance corrected Near visual acuity (DCNVA) [photopic] 6) Distance-corrected intermediate visual acuity (DCIVA) [photopic] 7) Low Contrast (10%) Distance Corrected Intermediate Visual Acuity [photopic] 8) Low Contrast (10%) Best Corrected Intermediate Visual Acuity [photopic] 9) Defocus curves monocular and binocular 10) Manifest refraction 11) Subject questionnaire 12) Subject ocular and visual symptoms (non-directed questions) 13) Rotational stability 14) Spherical equivalent Timepoint: Pre-operative, 1-2days, 7-14 days, 30-60 days, 120-180 days, 330- 420 days]	—

Measure

Time frame

1) Uncorrected distance visual acuity (UCDVA) [photopic] 2) Uncorrected intermediate visual acuity (UCIVA) [photopic] 3) Best corrected distance visual acuity (BCDVA) [photopic] 4) Uncorrected Near visual acuity (UCNVA) [photopic] 5) Distance corrected Near visual acuity (DCNVA) [photopic] 6) Distance-corrected intermediate visual acuity (DCIVA) [photopic] 7) Low Contrast (10%) Distance Corrected Intermediate Visual Acuity [photopic] 8) Low Contrast (10%) Best Corrected Intermediate Visual Acuity [photopic] 9) Defocus curves monocular and binocular 10) Manifest refraction 11) Subject questionnaire 12) Subject ocular and visual symptoms (non-directed questions) 13) Rotational stability 14) Spherical equivalent Timepoint: Pre-operative, 1-2days, 7-14 days, 30-60 days, 120-180 days, 330- 420 days]

—

Countries

India

Contacts

Public ContactDr Rajesh Sinha

AIIMS, NEW DELHI

sinharaj1@gmail.com9868937900

Outcome results

None listed

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