Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular Lenses

Completed

• Conditions: Cataract Senile
• Interventions: Diagnostic Test: The Quality of Vision questionnaire

• Registration Number: NCT04655274
• Lead Sponsor: Akdeniz University

Brief Summary

The purpose of the present study was to compare the clinical outcomes such as visual function, refraction errors and visual quality of patients undergoing cataract surgery with implantation of two different models of diffractive trifocal IOLs: RayOne Trifocal (Rayner IOL, Ltd.) and AcrySof IQ PanOptix (Alcon Laboratories, Inc.) IOL.

Detailed Description

Cataract is affecting over 95 million people worldwide and remains the leading cause of vision impairment and blindness. Cataract surgery is an effective method for restoring visual acuity (VA). With the advancement of cataract surgery technique and intraocular lenses (IOL) technologies, expectations of patients from cataract surgery have good vision at distance and near ranges without using spectacles. The standard IOLs design were monofocal, which offered only fixed focal distance. One of the main factors for dissatisfaction after monofocal pseudophakic eyes is lack of accommodation. Previous studies demonstrated that this problem can be resolved by using diffractive trifocal IOLs. Diffractive trifocal IOLs provide effective near, intermediate and distance visual restoration, and has been widely used in patients who want to achieve spectacle independence after surgery. However, some possible optical side effects of trifocal IOLs have been reported, including halos and other dysphotopsias, reduced contrast sensitivity (CS), glare disability, which can significantly affect visual quality and patient satisfaction. The purpose of the present study was to compare the clinical outcomes such as visual function, refraction errors and visual quality of patients undergoing cataract surgery with implantation of two different models of diffractive trifocal IOLs: RayOne Trifocal (Rayner IOL, Ltd.) and AcrySof IQ PanOptix (Alcon Laboratories, Inc.) IOL.

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Status Verified: 2021-03
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients underwent cataract surgery with trifocal intraocular lenses implantation in one or both eyes

Exclusion Criteria

• Amblyopia
• Axial length (AL) over 25 mm
• Previous history of corneal or refractive surgery
• Ocular comorbidity (corneal scars, keratoconus, and corneal endothelial dystrophy, chronic or recurrent uveitis, macular degeneration, diabetes mellitus with retinal changes, glaucoma or intraocular pressure equal or higher than 24 mmHg)
• Patient inability to understand and/or fill in patient questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RayOne Trifocal intraocular lenses	The Quality of Vision questionnaire	Eyes of patients undergoing cataract surgery with implantation of RayOne Trifocal (Rayner IOL, Ltd.) intraocular lenses
AcrySof IQ PanOptix intraocular lenses	The Quality of Vision questionnaire	Eyes of patients undergoing cataract surgery with implantation of AcrySof IQ PanOptix (Alcon Laboratories, Inc.) intraocular lenses

Primary Outcome Measures

Name	Time	Method
The Quality of Vision score	3 months	Glare, halos, starbursts, hazy/blurred/double vision, distortion, focusing difficulties, fluctuation, and depth perception

Trial Locations

Locations (1)

Aslı Çentinkaya Yaprak; 🇹🇷 Antalya, Turkey