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Clinical Trials/NCT04265846
NCT04265846
Unknown
Not Applicable

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

Peking University Third Hospital1 site in 1 country140 target enrollmentMay 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Presbyopia
Sponsor
Peking University Third Hospital
Enrollment
140
Locations
1
Primary Endpoint
monocular and binocular visual acuity
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 31, 2020
End Date
November 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

monocular and binocular visual acuity

Time Frame: 3 months postoperatively

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

economic efficiency

Time Frame: 3 months postoperatively

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.

Secondary Outcomes

  • Binocular Defocus Curve(3 months postoperatively)
  • Binocular Contrast sensitivity(3 months postoperatively)
  • stereopsis(3 months postoperatively)
  • Subjective visual quality(3 months postoperatively)
  • Fusion function(3 months postoperatively)

Study Sites (1)

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