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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04927117
• Other study ID #: SHAIER2021IRB02
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2021
• Source: Aier School of Ophthalmology, Central South University
• Contact: Xu Chen
• Phone: +8613601762646
• Email: Francois.chenxu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Intraocular Lens
• Myopia

Locations

Country	Name	City	State
China	Xu Chen	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

References & Publications (3)

Alió JL, Plaza-Puche AB, Alió Del Barrio JL, Amat-Peral P, Ortuño V, Yébana P, Al-Shymali O, Vega-Estrada A. Clinical outcomes with a diffractive trifocal intraocular lens. Eur J Ophthalmol. 2018 Jul;28(4):419-424. doi: 10.1177/1120672118762231. Epub 2018 — View Citation

García-Pérez JL, Gros-Otero J, Sánchez-Ramos C, Blázquez V, Contreras I. Short term visual outcomes of a new trifocal intraocular lens. BMC Ophthalmol. 2017 May 17;17(1):72. doi: 10.1186/s12886-017-0462-y. — View Citation

Kohnen T, Herzog M, Hemkeppler E, Schönbrunn S, De Lorenzo N, Petermann K, Böhm M. Visual Performance of a Quadrifocal (Trifocal) Intraocular Lens Following Removal of the Crystalline Lens. Am J Ophthalmol. 2017 Dec;184:52-62. doi: 10.1016/j.ajo.2017.09.016. Epub 2017 Sep 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length (AL)	Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)	1 minute
Primary	Uncorrected distance visual acuity	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).	10 minutes
Primary	Uncorrected near visual acuity	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).	10 minutes
Primary	Uncorrected intermediate visual acuity	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)	10 minutes
Primary	contrast sensitivity	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	30 minutes