NCT04265820

Brief Summary

This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

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

October 28, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

November 26, 2019

Last Update Submit

February 10, 2020

Conditions

Cataract

Keywords

unilateral cataractbinocular functional visionMultifocal Intraocular Lenses

Outcome Measures

Primary Outcomes (1)

  • monocular and binocular visual acuity

    uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity will be measured at 5m, 80cm and 40cm respectively. All visual acuity measurements will be conducted under photopic conditions (85 cd/m2) and at 100% contrast

    3 months postoperatively

Secondary Outcomes (5)

  • Binocular Contrast sensitivity

    3 months postoperatively

  • Binocular Defocus Curve

    3 months postoperatively

  • stereopsis

    3 months postoperatively

  • Fusion function

    3 months postoperatively

  • Subjective visual quality

    3 months postoperatively

Study Arms (2)

Group 1

EXPERIMENTAL

The unilateral cataract patients in the Group 1 will undergo phacoemulsification and unilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs.

Device: unilateral implantation of IOL

Group 2

ACTIVE COMPARATOR

The bilateral cataract patients in the Group 2 will undergo phacoemulsification and bilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs.

Device: bilateral implantation of IOL

Interventions

unilateral implantation of IOLDEVICE

unilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.

Group 1
bilateral implantation of IOLDEVICE

bilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.

Group 2

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with unilateral or bilateral age related cataracts
  • Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter

You may not qualify if:

  • Pregnant or nursing women
  • In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
  • Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
  • History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
  • Patients with history of ocular trauma or prior ocular surgery including refractive procedures
  • postoperative visual acuity of worse than 0.2 logMAR in any eye
  • Patients using systemic or ocular medication that affect visual acuity.
  • Patients participating in other clinical trials during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Qi Hong, PhD，MD

    Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

Qianqian Lan

CONTACT

+861860771197254283122@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

February 12, 2020

Study Start

October 28, 2019

Primary Completion

May 1, 2020

Study Completion

August 1, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)