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

Study Overview
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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.

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

Conditions
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Presbyopia, Cataract Senile

Intervention / Treatment
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* Device: bifocal IOL
* Device: mix bifocal IOL
* Device: trifocal IOL
* Device: EDOF IOL
* Device: different IOLs
* Device: monofocal IOL
* Device: monofocal IOL


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bifocal IOL group<br>The cataract patients who ask for bilateral phacoemulsification and bifocal IOLs implantation. | Device: bifocal IOL<br>* The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.<br>|
| mix bifocal IOL group<br>The cataract patients who ask for phacoemulsification and mix different bifocal IOLs implantation bilaterally | Device: mix bifocal IOL<br>* The patients will undergo phacoemulsification and mix different bifocal IOLs implantation bilaterally.<br>|
| trifocal IOL group<br>The cataract patients who ask for bilateral phacoemulsification and trifocal IOLs implantation. | Device: trifocal IOL<br>* The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.<br>|
| EDOF IOL group<br>The cataract patients who ask for bilateral phacoemulsification and EDOF IOLs implantation. | Device: EDOF IOL<br>* The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.<br>|
| blend vision group<br>The cataract patients who ask for phacoemulsification and different IOLs implantation bilaterally. | Device: different IOLs<br>* The patients will undergo phacoemulsification and different IOLs implantation bilaterally.<br>|
| monovision designed group<br>The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with monovision designed. | Device: monofocal IOL<br>* The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.<br>|
| monofocal IOL group<br>The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed. | Device: monofocal IOL<br>* The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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