Comparison of two types of lenses used for eye surgery

Recruiting

• Conditions: Cataract

• Registration Number: CTRI/2018/02/011832
• Lead Sponsor: Biotech Vision Care Pvt Ltd

Brief Summary

This prospective study aims at assessing and comparingthe visual outcomes in patients undergoing restore (AcrySof® IQ ReSTOR®) and biotech (Eyecryl ACTV Diffractive) multifocal IOL implantation afteruneventful cataract surgery. Patients undergoing bilateral cataract surgeryfrom the period of May 2017 to April2018 will be included in the study. Aperiod up of   six monthswill be consideredfor analysis of data. Certain parameters will be evaluated to determine theoutcome such as visual acuity, contrast sensitivity, higher order aberrations,patient’s visual satisfaction (with the help of VFQ-33 questionnaire) postcataract surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-24
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patients who has been implanted bilaterally with any one of the Multifocal IOL: Eyecryl ACTV Diffractive Multifocal IOL OR AcrySof® IQ ReSTOR® multifocal IOL will be included in the study.
• Age 18 and older Regular corneal topography and corneal astigmatism Preoperative & postoperative corneal astigmatism of ≤ 0.75D Clear intraocular media Availability, willingness and sufficient cognitive awareness to comply with examination procedures Written informed consent for participation in the study and data protection.

Exclusion Criteria

• Patients with best corrected vision less than 6/9 and or N/6 Pupil Size: > 5 mm scotopic size Previous ocular surgery.
• Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism) Any ocular pathology (corneal, retinal) Subject who are professional Pilots/truck/Car Drivers.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast sensitivity(Low and High)	Pre Operative | 1 month | 3 months | 6 months
To Compare Visual acuity (Distance, Near and Intermediate vision),	Pre Operative | 1 month | 3 months | 6 months

Secondary Outcome Measures

Name	Time	Method
High Order aberrations	Reading Speed

Trial Locations

Locations (1)

Laxmi Eye Institute and Charitable Trust; 🇮🇳 Raigarh, MAHARASHTRA, India

Laxmi Eye Institute and Charitable Trust

🇮🇳Raigarh, MAHARASHTRA, India

DR S S HALDIPURKAR

Principal investigator

22-27452228

info@laxmieye.org