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

• Conditions: Cataract; Intraocular Lens; Myopia

• Registration Number: NCT04927117
• Lead Sponsor: Aier School of Ophthalmology, Central South University

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

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 Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-03
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-15
• Last Update Posted: 2021-06-15
• Primary Completion: 2022-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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)
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).
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

Trial Locations

Locations (1)

Xu Chen; 🇨🇳 Shanghai, China