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Clinical assessment of a new type of extended range of intraocular lenses in improving vision after cataract surgery

Clinical outcomes and quality of vision with new Extended Range Of Vision (ERV) Intraocular Lenses

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/10/006246
Enrollment
50
Registered
2015-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- CATARACT

Interventions

Intervention1: PRE-OP NEAR, INTERMEDIATE AND DISTANCE VISUAL ACUITY.: PRE-OP NEAR, INTERMEDIATE AND DISTANCE VISUAL ACUITY. Control Intervention1: POST-OP NEAR, INTERMEDIATE AND DISTANCE VISUAL ACUITY

Sponsors

DR SRI GANESH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who are willing for bilateral implantation / second eye surgery within one week of first eye will be included. 2.Patients of any gender, age group : 40 to 80 years 3.Healthy eyes besides cataract 4.Assured follow-up examinations 5.Stable corneal conditions within the last 12 months 6.Corneal astigmatism less than 1D 7.Implantation into the capsular bag by injector

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA: Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders) Pseudophakia Cornea guttata; keratoplasty Irregular astigmatism (e.g. Keratoconus) Corneal scarring Diabetic retinopathy and other fundal pathologies Aniridia Amblyopia Previous intraocular (corneal, glaucoma or vitreo retinal)surgery Pseudoexfoliation Syndrome; Uveitis Intraocular tumours; endotamponade Glaucoma or IOP higher than 24mmHg Need for a dioptre out of the range of +16.0D to +26.0D Inability to achieve secure lens placement in the capsular bag Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis

Design outcomes

Primary

MeasureTime frame
This trial is aimed to evaluate the improvement in intermediate visual acuity while maintaining far and near vision with ERV IOL.Timepoint: vision will be assessed at postoperative day 7, day 30 and day 90—

Secondary

MeasureTime frame
Evaluation of contrast sensitivity and depth of focus UCVA and BCVA for far and near vision Reading performancewith Salzbug Reading Desk Subjective assessment of visual disturbances, patient satisfaction and spectacle independence Timepoint: PRE-OP, POST -OP DAY1 , DAY 7 AND 1 MONTH , 3 MONTHS, 6 MONTHS AND 12 MONTHS.—

Countries

India

Contacts

Public ContactSRI GANESH

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL

phacomaverick@gmail.com9845129740

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 25, 2026