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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265846
• Other study ID #: 20191129
• Status: Recruiting
• Start date: May 31, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2022
• Source: Peking University Third Hospital
• Contact: Qianqian Lan
• Phone: +8618607711972
• Email: 54283122[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 1, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Presbyopia

Intervention

Device:
• bifocal IOL
The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.
• mix bifocal IOL
The patients will undergo phacoemulsification and mix different bifocal IOLs implantation bilaterally.
• trifocal IOL
The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.
• EDOF IOL
The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.
• different IOLs
The patients will undergo phacoemulsification and different IOLs implantation bilaterally.
• monofocal IOL
The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.
• monofocal IOL
The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	People's Hospital of Guangxi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Fusion function	The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.	3 months postoperatively
Secondary	Subjective visual quality	Using NEI-VFQ-25 questionnaire (Chinese version). Photic phenomena, spectacle independence, and satisfaction questionnaire.	3 months postoperatively