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

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655274
• Other study ID #: 2020-11
• Status: Completed
• Start date: November 30, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: March 2021
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

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.

Locations

Country	Name	City	State
Turkey	Asli Çentinkaya Yaprak	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Quality of Vision score	Glare, halos, starbursts, hazy/blurred/double vision, distortion, focusing difficulties, fluctuation, and depth perception	3 months