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

NCT ID: NCT04265846

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-31

Study Completion Date

2022-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Presbyopia Cataract Senile

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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bifocal IOL group

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

bifocal IOL

Intervention Type DEVICE

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

mix bifocal IOL

Intervention Type DEVICE

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.

trifocal IOL

Intervention Type DEVICE

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.

EDOF IOL

Intervention Type DEVICE

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.

different IOLs

Intervention Type DEVICE

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.

monofocal IOL

Intervention Type DEVICE

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

monofocal IOL group

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

monofocal IOL

Intervention Type DEVICE

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

Interventions

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bifocal IOL

The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.

Intervention Type DEVICE

mix bifocal IOL

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

Intervention Type DEVICE

trifocal IOL

The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.

Intervention Type DEVICE

EDOF IOL

The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.

Intervention Type DEVICE

different IOLs

The patients will undergo phacoemulsification and different IOLs implantation bilaterally.

Intervention Type DEVICE

monofocal IOL

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

Intervention Type DEVICE

monofocal IOL

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qi Hong, PhD,MD

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qianqian Lan

Role: CONTACT

+8618607711972

Facility Contacts

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Hong Qi, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40389895 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36266642 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36071311 (View on PubMed)

Other Identifiers

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20191129

Identifier Type: -

Identifier Source: org_study_id

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