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Status unknownNCT04927117Updated Jun 15, 2021

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

An observational study in Cataract, Myopia and Intraocular Lens, sponsored by Aier School of Ophthalmology, Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-15.

Sponsored by Aier School of Ophthalmology, Central South University · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 90 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cataract
  • Myopia
  • Intraocular Lens

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Keywords

  • Myopia
  • visual acuity
  • monocular defocus curve
  • binocular contrast sensitivity
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Myopic Cataract Patients

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • high myopic group (group1:AL≥26.0 mm)

    axial length≥26.0 mm)

  • age-matched control group

    axial length\<26.0mm

05

What researchers measure

Primary outcomes

  1. Axial length (AL)

    Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)

    Time frame: 1 minute

  2. 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).

    Time frame: 10 minutes

  3. 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).

    Time frame: 10 minutes

  4. 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)

    Time frame: 10 minutes

  5. 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

    Time frame: 30 minutes

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • 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. PubMed 28923587 ↗
  • 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. PubMed 28514944 ↗
  • 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. PubMed 29619883 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04927117
Lead sponsor
Aier School of Ophthalmology, Central South University
Responsible party
Sponsor
First posted
Jun 15, 2021
Start date
Jul 1, 2020
Primary completion
Jul 1, 2022 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
Jun 15, 2021

Study contacts

Xu Chen
Contact
Francois.chenxu@gmail.com
+8613601762646
Xu Chen
study director · Shanghai Aier Eye Hospital China.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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