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

Sponsor
Akdeniz University (Other)
Overall Status
Completed
CT.gov ID
NCT04655274
Collaborator
(none)
30
1
3.9
7.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The Quality of Vision questionnaire

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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular Lenses
Actual Study Start Date :
Nov 30, 2020
Actual Primary Completion Date :
Mar 30, 2021
Actual Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm Intervention/Treatment
RayOne Trifocal intraocular lenses

Eyes of patients undergoing cataract surgery with implantation of RayOne Trifocal (Rayner IOL, Ltd.) intraocular lenses

Diagnostic Test: The Quality of Vision questionnaire
The Quality of Vision questionnaire rates glare, halos, starbursts, hazy/blurred/double vision, distortion, focusing difficulties, fluctuation, and depth perception conditions.

AcrySof IQ PanOptix intraocular lenses

Eyes of patients undergoing cataract surgery with implantation of AcrySof IQ PanOptix (Alcon Laboratories, Inc.) intraocular lenses

Diagnostic Test: The Quality of Vision questionnaire
The Quality of Vision questionnaire rates glare, halos, starbursts, hazy/blurred/double vision, distortion, focusing difficulties, fluctuation, and depth perception conditions.

Outcome Measures

Primary Outcome Measures

  1. The Quality of Vision score [3 months]

    Glare, halos, starbursts, hazy/blurred/double vision, distortion, focusing difficulties, fluctuation, and depth perception

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aslı Çentinkaya Yaprak Antalya Turkey 070059

Sponsors and Collaborators

  • Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aslı Çetinkaya Yaprak, Principal Investigator, Akdeniz University
ClinicalTrials.gov Identifier:
NCT04655274
Other Study ID Numbers:
  • 2020-11
First Posted:
Dec 7, 2020
Last Update Posted:
Apr 2, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2021