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

• Conditions: Presbyopia; Cataract Senile

• Registration Number: NCT04265846
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Study Start: 2020-05-31
• Status Verified: 2022-03
• Primary Completion: 2022-05-31
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
monocular and binocular visual acuity	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China