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

NCT ID: NCT04927117

Last Updated: 2021-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-07-01

Brief Summary

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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

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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.

Conditions

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Cataract Myopia Intraocular Lens

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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high myopic group (group1:AL≥26.0 mm)

axial length≥26.0 mm)

No interventions assigned to this group

age-matched control group

axial length\<26.0mm

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xu Chen

Role: STUDY_DIRECTOR

Shanghai Aier Eye Hospital China.

Locations

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Xu Chen

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xu Chen

Role: CONTACT

+8613601762646

Facility Contacts

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Xu Chen

Role: primary

+8613601762646

Adilamu Abulimiti

Role: backup

+8618616770462

References

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Kohnen T, Herzog M, Hemkeppler E, Schonbrunn S, De Lorenzo N, Petermann K, Bohm 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.

Reference Type BACKGROUND
PMID: 28923587 (View on PubMed)

Garcia-Perez JL, Gros-Otero J, Sanchez-Ramos C, Blazquez 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.

Reference Type RESULT
PMID: 28514944 (View on PubMed)

Alio JL, Plaza-Puche AB, Alio Del Barrio JL, Amat-Peral P, Ortuno V, Yebana 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 Apr 5.

Reference Type RESULT
PMID: 29619883 (View on PubMed)

Other Identifiers

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SHAIER2021IRB02

Identifier Type: -

Identifier Source: org_study_id

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