NCT04266847

Brief Summary

This is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.

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
60

participants targeted

Target at P25-P50 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 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 29, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

November 29, 2019

Last Update Submit

February 10, 2020

Conditions

Cataract Senile

Keywords

unilateral cataractbinocular functional visionMultifocal Intraocular Lenses

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

unilateral mild cataract patients

EXPERIMENTAL

The patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye.

Device: monofocal IOL,bifocal IOL,or trifocal IOL

Interventions

monofocal IOL,bifocal IOL,or trifocal IOLDEVICE

phacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL

unilateral mild cataract patients

Eligibility Criteria

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

You may qualify if:

  • Patients who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye
  • Regular corneal topography and 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.)
  • In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR after surgery (amblyopia, strabismus, keratoconus, etc.)
  • Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
  • Patients using systemic or ocular medication that affect visual acuity.
  • Patients with history of ocular trauma or prior ocular surgery including refractive procedures
  • 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

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2019

First Posted

February 12, 2020

Study Start

October 30, 2019

Primary Completion

June 1, 2020

Study Completion

September 1, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)