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

Not Applicable

• Conditions: Health Condition 1: null- CATARACT

• Registration Number: CTRI/2015/10/006246
• Lead Sponsor: DR SRI GANESH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 50

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:

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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