Evaluation of Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens

Sponsor

Aier School of Ophthalmology, Central South University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04927117

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The PanOptix trifocal IOL is a new trifocal intraocular lens which is proved to provide good range of vision for distance, intermediate and near and good visual quality in cataract patients with normal axial length. But whether it can get the same visual quality in myopia is still unknown

Condition or Disease	Intervention/Treatment	Phase
Cataract Myopia Intraocular Lens

Detailed Description

There are a few publications of multi-focal IOLs on Chinese patients with high myopia. From published papers, it is known that performance of multifocal IOLs is satisfied in myopic patients. However there is no publication to investigate PanOptix in moderate and high myopic patients. So it is imperative to demonstrate good performance of PanOptix in those special patients. The purpose of this study is to assess visual performance and patient satisfaction after the implantation of PanOptix in myopic patients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of Binocular Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens : a 2 Years Prospective, Observational, Multi-center Study

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
high myopic group (group1:AL≥26.0 mm) axial length≥26.0 mm)
age-matched control group axial length<26.0mm

Outcome Measures

Primary Outcome Measures

Axial length (AL) [1 minute]
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
Uncorrected distance visual acuity [10 minutes]
Uncorrected distance visual acuity (4m) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Uncorrected near visual acuity [10 minutes]
Uncorrected near visual acuity (40cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Uncorrected intermediate visual acuity [10 minutes]
Uncorrected intermediate visual acuity (60cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA)
contrast sensitivity [30 minutes]
Binocular contrast sensitivity was measured at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the functional acuity contrast test(Test SV-1000) of the CC-100 HW 5.0 Series system

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Axial myopic patients（Refractive condition match the axial length after eliminate the nuclear cataract induced myopia factor）
Corneal astigmatism <1.0D (IOL-Master 500/700, Carl Zeiss Meditec, Jena, Germany);
Eyes with pupil diameter>2.5 mm (Photopic) and<6 mm (Mesopic) (Pentacam HR, Oculus Optikgerate GmbH);
Eyes with angle kappa<0.50 mm (Pentacam HR);
Eyes with corneal spherical aberration<0.50 (Pentacam HR)

Exclusion Criteria:

Irregular corneal astigmatism
Any retinal disease, macular disease(Including myopic MD and retinal diseases) could affect VA, glaucoma and other severe intraocular diseases
Moderate-severe dry eye
Amblyopia（BCDVA<0.7 before cataract appears）
Patients having difficulties with examinations or 3 months' follow-up.