NCT04927117

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 15, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

June 9, 2021

Last Update Submit

June 9, 2021

Conditions

CataractMyopiaIntraocular Lens

Keywords

Myopiavisual acuitymonocular defocus curvebinocular contrast sensitivity

Outcome Measures

Primary Outcomes (5)

  • Axial length (AL)

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

    1 minute

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

high myopic group (group1:AL≥26.0 mm)

axial length≥26.0 mm)

age-matched control group

axial length\<26.0mm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Myopic Cataract Patients

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xu Chen

Shanghai, 200000, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28923587BACKGROUND

  • 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.

    PMID: 28514944RESULT

  • 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.

    PMID: 29619883RESULT

MeSH Terms

Conditions

CataractMyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Xu Chen

    Shanghai Aier Eye Hospital China.

    STUDY DIRECTOR

Central Study Contacts

Xu Chen

CONTACT

+8613601762646Francois.chenxu@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 15, 2021

Study Start

July 1, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

June 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)