Clinical trial NCT04265846: Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
Official title: Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presbyopia
Cataract Senile
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: People's Hospital of Guangxi Zhuang Autonomous Region
First posted: 2020-02-12
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bilateral cataract

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: monocular and binocular visual acuity
timeFrame: 3 months postoperatively
measure: economic efficiency
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Binocular Contrast sensitivity
timeFrame: 3 months postoperatively
measure: Binocular Defocus Curve
timeFrame: 3 months postoperatively
measure: stereopsis
timeFrame: 3 months postoperatively
measure: Fusion function
timeFrame: 3 months postoperatively
measure: Subjective visual quality
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qi Hong, PhD，MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.