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Status unknownNCT04265846Updated Aug 12, 2022

Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia

An observational study in Presbyopia and Cataract Senile, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-12.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens Implantation designed for the correction of presbyopia.The subjects will undergo bilateral uneventful phacoemulsification and implantation of IOL.The subjects will be divided into several groups according to the type of the IOLs,including monofocal IOL group,monovision designed group ,bifocal IOL group, mix bifocal IOL group,trifocal IOL group,Exteded Depth of Focus(EDOF) IOL group and blend vision group. Compare the Subjective and objective visual quality and economic efficiency among these groups at 3 months postoperatively.

02

Conditions studied

  • Presbyopia
  • Cataract Senile
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 140 is above the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with bilateral cataract

Inclusion criteria

  • Patients with bilateral cataract
  • Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Devicebifocal IOL

    The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.

  • Devicemix bifocal IOL

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

  • Devicetrifocal IOL

    The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.

  • DeviceEDOF IOL

    The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.

  • Devicedifferent IOLs

    The patients will undergo phacoemulsification and different IOLs implantation bilaterally.

  • Devicemonofocal IOL

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

  • Devicemonofocal IOL

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

06

What researchers measure

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

    Time frame: 3 months postoperatively

  2. 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.

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Binocular Contrast sensitivity

    Contrast sensitivity measures will be conducted binocularly, under photopic, mesopic (5 cd/m2), photopic with glare and mesopic with glare conditions, with the OPTEC 6500 contrast sensitivity test (Stereo Optical, USA). Contrast sensitivity will be evaluated at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree \[cpd\]). Patients will be allowed 5 minutes to adapt to each illumination level before testing.

    Time frame: 3 months postoperatively

  2. Binocular Defocus Curve

    Binocular defocus curves will be obtained in all patients, positioned at 5m under photopic (\>85 cd/m 2 ) condition to measure the visual acuity with each defocus lens, representing the consecutive visual function of each eye. Negative lenses were added in 0.50 D steps and the visual acuity will be recorded for each type of defocus level. The procedure will be then repeated but with positive lenses. The range of defocus evaluated is from -4.00D to +2.00D.

    Time frame: 3 months postoperatively

  3. stereopsis

    distant stereopsis will be measured by block diagram of random-spot synoptophore, while near stereopsis will be measured by Yan's stereogram.

    Time frame: 3 months postoperatively

  4. Fusion function

    The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.

    Time frame: 3 months postoperatively

  5. Subjective visual quality

    Using NEI-VFQ-25 questionnaire (Chinese version). Photic phenomena, spectacle independence, and satisfaction questionnaire.

    Time frame: 3 months postoperatively

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36266642 ↗
  • 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. PubMed 36071311 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04265846
Lead sponsor
Peking University Third Hospital
Collaborators
People's Hospital of Guangxi
Responsible party
Sponsor
First posted
Feb 12, 2020
Start date
May 31, 2020
Primary completion
May 31, 2022
Completion
Nov 1, 2022 (estimated)
Last update
Aug 12, 2022

Study contacts

Qianqian Lan
Contact
54283122@qq.com
+8618607711972
Qi Hong, PhD,MD
study director · Peking University Third Hospital

Oversight

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

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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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