NCT04655274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

November 30, 2020

Last Update Submit

March 31, 2021

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

  • The Quality of Vision score

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

    3 months

Study Arms (2)

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

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

Interventions

The Quality of Vision questionnaireDIAGNOSTIC_TEST

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 lensesRayOne Trifocal intraocular lenses

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent cataract surgery with trifocal intraocular lenses implantation in one or both eyes at Akdeniz University Hospital Ophtalmology Department.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aslı Çentinkaya Yaprak

Antalya, 070059, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

November 30, 2020

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)