NCT04265846

Brief Summary

Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens(IOLs) implantation designed for the correction of presbyopia.

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
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

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

Study Start

First participant enrolled

May 31, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 12, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

November 29, 2019

Last Update Submit

August 9, 2022

Conditions

PresbyopiaCataract Senile

Outcome Measures

Primary Outcomes (2)

  • 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

  • economic efficiency

    economic efficiency was defined as the ratio of objective spectacle independence (UCVA better than 0.10 logMAR) and IOL price, then compare the economic efficiency among different groups.

    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 (7)

bifocal IOL group

The cataract patients who ask for bilateral phacoemulsification and bifocal IOLs implantation.

Device: bifocal IOL

mix bifocal IOL group

The cataract patients who ask for phacoemulsification and mix different bifocal IOLs implantation bilaterally

Device: mix bifocal IOL

trifocal IOL group

The cataract patients who ask for bilateral phacoemulsification and trifocal IOLs implantation.

Device: trifocal IOL

EDOF IOL group

The cataract patients who ask for bilateral phacoemulsification and EDOF IOLs implantation.

Device: EDOF IOL

blend vision group

The cataract patients who ask for phacoemulsification and different IOLs implantation bilaterally.

Device: different IOLs

monovision designed group

The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.

Device: monofocal IOL

monofocal IOL group

The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.

Device: monofocal IOL

Interventions

bifocal IOLDEVICE

The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.

bifocal IOL group
mix bifocal IOLDEVICE

The patients will undergo phacoemulsification and mix different bifocal IOLs implantation bilaterally.

mix bifocal IOL group
trifocal IOLDEVICE

The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.

trifocal IOL group
EDOF IOLDEVICE

The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.

EDOF IOL group
different IOLsDEVICE

The patients will undergo phacoemulsification and different IOLs implantation bilaterally.

blend vision group
monofocal IOLDEVICE

The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.

monovision designed group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with bilateral cataract

You may qualify if:

  • Patients with bilateral cataract
  • 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

Related Publications (3)

  • Sun T, Zhao X, Liu Y, Lan Q, Tang C, Qin R, Bian L, Li W, Qi H. Neurosensory binocular vision after bilateral implantation of an extended depth of focus intraocular lens with micro-monovision: a prospective cohort study. BMC Ophthalmol. 2025 May 19;25(1):294. doi: 10.1186/s12886-025-04125-5.

    PMID: 40389895DERIVED

  • Sun T, Liu Y, Gao Y, Tang C, Lan Q, Yang T, Zhao X, Qi H. Comparison of visual outcomes of a diffractive trifocal intraocular lens and a refractive bifocal intraocular lens in eyes with axial myopia: a prospective cohort study. BMC Ophthalmol. 2022 Oct 20;22(1):407. doi: 10.1186/s12886-022-02626-1.

    PMID: 36266642DERIVED

  • Lan Q, Liu Y, Xu F, Li M, Li Y, Yang T, Sun T, Yao G, Ma B, Tao L, Xiao X, Feng XL, Zeng S, Qi H. Cost-Effectiveness of Presbyopia Correction Among Seven Strategies of Bilateral Cataract Surgery Based on a Prospective Single-Blind Two-Center Trial in China. Ophthalmol Ther. 2022 Dec;11(6):2067-2082. doi: 10.1007/s40123-022-00562-3. Epub 2022 Sep 7.

    PMID: 36071311DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye 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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2019

First Posted

February 12, 2020

Study Start

May 31, 2020

Primary Completion

May 31, 2022

Study Completion

November 1, 2022

Last Updated

August 12, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)