Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

Phase 2

Completed

• Conditions: Refractive Errors
• Interventions: Device: Trifocal diffractive intraocular lens

• Registration Number: NCT04465279
• Lead Sponsor: Alexandria University

Brief Summary

Multifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

Detailed Description

Monofocal IOLs, which provide effective distance vision, currently account for the majority of IOLs implantations. Patients who have undergone cataract surgery with implantation of monofocal IOL may require spectacles to perform near-distance (e.g., reading) or intermediate-distance (e.g., using a computer) tasks depending on their visual demandsMultifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

Study Timeline

• Study Start: 2018-10-15
• Primary Completion: 2020-05-15
• Status Verified: 2020-06
• Study Completion: 2020-06-15
• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patient eyes had cataract with no other pathology, patients desire for spectacle independence after surgery and with realistic expectation.

Exclusion Criteria

• Any ocular comorbidity that affect the end results of the surgery, history of ocular trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular abnormalities that may affect postoperative centration as tilt of the lens (e.g. pseudo exfoliation syndrome and Marfan's syndrome).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trifocal Diffractive Intraocular Lens (FineVision)	Trifocal diffractive intraocular lens	36 eyes having implantation of trifocal diffractive IOL (FineVision)

Primary Outcome Measures

Name	Time	Method
Visual Acuity	3 months	Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision
Defocus curve	3 months	examined monocular and binocular after correcting distant VA refractive error then inserting defocus lenses 0.50-D focus steps from (+1.50 to -3.50 D) in the trial frame

Secondary Outcome Measures

Name	Time	Method
Contrast sensitivity	3 months	using the CSV-1000 contrast test.
Visual Satisfaction Questionnaire	3 months	Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).

Trial Locations

Locations (1)

Alexandria Faculty of Medicine; 🇪🇬 Alexandria, Egypt