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

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

Study Overview

• Status: Recruiting
• Conditions: Presbyopia; Cataract Senile
• Intervention / Treatment: Device: bifocal IOL; Device: mix bifocal IOL; Device: trifocal IOL; Device: EDOF IOL; Device: different IOLs; Device: monofocal IOL; Device: monofocal IOL

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.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: QIanqian Lan; Phone Number: +8618607711972; Email: 54283122@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with bilateral cataract

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bifocal IOL group; The cataract patients who ask for bilateral phacoemulsification and bifocal IOLs implantation.	Device: bifocal IOL; The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.
mix bifocal IOL group; The cataract patients who ask for phacoemulsification and mix different bifocal IOLs implantation bilaterally	Device: mix bifocal IOL; The patients will undergo phacoemulsification and mix different bifocal IOLs implantation bilaterally.
trifocal IOL group; The cataract patients who ask for bilateral phacoemulsification and trifocal IOLs implantation.	Device: trifocal IOL; The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.
EDOF IOL group; The cataract patients who ask for bilateral phacoemulsification and EDOF IOLs implantation.	Device: EDOF IOL; The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.
blend vision group; The cataract patients who ask for phacoemulsification and different IOLs implantation bilaterally.	Device: different IOLs; The patients will undergo phacoemulsification and different IOLs implantation bilaterally.
monovision designed group; The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.	Device: monofocal IOL; The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.; Device: monofocal IOL; The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.
monofocal IOL group; The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.	Device: monofocal IOL; The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.; Device: monofocal IOL; The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months postoperatively
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.	3 months postoperatively
Fusion function	The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.	3 months postoperatively
stereopsis	distant stereopsis will be measured by block diagram of random-spot synoptophore, while near stereopsis will be measured by Yan's stereogram.	3 months postoperatively
Subjective visual quality	Using NEI-VFQ-25 questionnaire (Chinese version). Photic phenomena, spectacle independence, and satisfaction questionnaire.	3 months postoperatively

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: People's Hospital of Guangxi
• Investigators: Study Director: Qi Hong, PhD，MD, Peking University Third Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: 20191129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No