Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04522427

Collaborator

(none)

114

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center, randomized, open, positive product, parallel controlled trial to evaluate the clinical outcomes of presbyopia-correcting intraocular lenses(IOLs) in eyes with previous corneal refractive surgery.

Specific Aim 1 (Primary): To compare the surgical successful rate of Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.

Specific Aim 2 (Secondary): To study the suboptimal surgical outcomes between Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract Presbyopia	Device: Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs) Device: Use Monofocal intraocular lenses(IOLs)	N/A

Detailed Description

Recently, the demands for myopia correction and corneal refractive laser surgery are rising with the increased prevalence of myopia. Corneal laser refractive surgery includes photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), laser-assisted subepithelial keratomileusis ( LASEK), femtosecond assisted laser in situ keratomileusis (FS-LASIK), and small incision lenticule extraction(SMILE). At present, FS-LASIK and SMILE are the mainstream methods for correcting myopia refractive surgery with advantages of safety, reliability, predictability and stability compared with other types of refractive surgery. Cataract is the most important cause of blindness in my country and even in the world. More than 50% of blind people are caused by cataract. Many patients who have undergone corneal laser refractive surgery may develop presbyopia or cataracts with age. Phacoemulsification and intraocular lens(IOLs) implantation are the main methods for cataract due to lacking effective pharmaceutical treatments. In addition, the patients who use traditional monofocal IOLs without the ability of accommodation may fail to get rid of glasses. Therefore, a solution that can provide both distance vision and near vision is needed to the presbyopia or cataracts patients with previous corneal refractive surgery and accustomed to taking glasses off.The application of presbyopic IOL in cataract after corneal refractive surgery become extensive with the IOL technology continuously advancing, including Extended Depth-of-Focus(EDOF) IOL, multifocal IOL(especially trifocal IOL) and so on, which can improve the distance, middle, and near visual acuity conducing to reduce the rate of wearing glasses after cataract surgery.

This project is a single-center, randomized, open, positive product, parallel controlled trial to study the clinical outcomes and applied value of presbyopic IOLs, including EDOF and trifocal IOLs after corneal laser refractive surgery complicated with cataracts, and seek better solutions to enable patients to achieve satisfactory visual quality and refractive results after surgery, culminating in completing patients' demand of taking glasses off.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Laser Refractive Surgery

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multifocal and Extended Depth-of-Focus intraocular lenses Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation	Device: Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs) IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
Active Comparator: Monofocal intraocular Lenses Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation	Device: Use Monofocal intraocular lenses(IOLs) Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS

Arm

Intervention/Treatment

Experimental: Multifocal and Extended Depth-of-Focus intraocular lenses

Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation

Device: Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)

IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF

Active Comparator: Monofocal intraocular Lenses

Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation

Device: Use Monofocal intraocular lenses(IOLs)

Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS

Outcome Measures

Primary Outcome Measures

Postoperative UDVA measured with standard visual acuity charts [Measured 3 months after cataract surgery]
postoperative uncorrected distance visual acuity(UDVA)
Postoperative UIVA measured with standard visual acuity charts [Measured 3 months after cataract surgery]
Postoperative uncorrected intermediate visual acuity(UIVA)
Postoperative UNVA measured with standard visual acuity charts [Measured 3 months after cataract surgery]
Postoperative uncorrected near visual acuity(UNVA)

Secondary Outcome Measures

monocular vision measured with standard visual acuity charts [Measured first day, first week, first month, 3 months, and 6 months after cataract surgery]
Uncorrected distance visual acuity and best corrected distance visual acuity
monocular vision measured with standard visual acuity charts [Measured 1 month, 3 months, and 6 months after cataract surgery]
Uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity
Diopter measured by Phorometer [Measured 1 month, 3 months, and 6 months after cataract surgery]
Important factor affecting the improvement of postoperative visual function
IOL rotation stability [Measured first day, first week, first month, 3 months, and 6 months after cataract surgery]
The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX) [Measured 1 month, 3 months, and 6 months after cataract surgery]
total aberration, total low-order aberration, and total high-order aberration
Contrast sensitivity measured by FACT chart [Measured 6 months after cataract surgery]
Provide accurate and comprehensive objective basis for the evaluation of visual function of cataract patients
Binocular vision measured with standard visual acuity charts [Measured 6 months after cataract surgery]
Uncorrected distance visual acuity, best corrected distance visual acuity, uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity.
The rate of IOL dislocation [Measured 6 months after cataract surgery]
Effectiveness evaluation index
Defocus Curve [Measured 6 months after cataract surgery]
Drawing Defocus Curve after taking the average of the data collected in each group of patients
Postoperative satisfaction：Chinese version visual function index-12(VF-12-CN) [Measured 6 months after cataract surgery]
Questionnaire survey on patients' quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The operated eye has ever undergone corneal refractive surgery, including PRK, LASIK, LASEK, FS-LASIK, SMILE and excluding RK
At least one eye suffering from cataract and expected to undergo phacoemulsification and IOL implantation and cataract nuclei rigidity in the operated eye from 1 to 3 degree
Expected to use intraocular lens power in -10.0D~+30.0D
Willing and able to comply with scheduled visits and other study procedures.
The need to decrease the dependence of glasses
Signing an informed consent form

Exclusion Criteria:

Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
The density of corneal endothelial cells is lower than 2000/mm2
The natural diameter of the pupil under the darkroom is less than 3mm or greater than 5.5mm
The Kappa or Alpha angle of the operated eye is greater than 0.5mm, or the Kappa angle is greater than half of the diameter of the central refractive optical zone in the multifocal intraocular lens
Patients with expected best corrected distance visual acuity(BCDVA) less than 0.5 (decimal vision)
Occurrence of irregular corneal astigmatism that affects postoperative vision
Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye
Pregnant, lactation or planning to become pregnant in the near future
Any surgical contraindications
Uncontrolled systemic or ocular disease
Use of any systemic or topical drug known to interfere with visual performance
Other ocular surgery at the time of the cataract extraction
Traumatic cataract or congenital bilateral cataract in the operated eye
Getting used to reading with glasses
High requirements for visual functions in patients' career or daily life
Professional drivers or frequent outdoor workers at night
A medical history of photophobia
Amblyopia
Excessive vision expectations after surgery or too sensitive, nervous, depressed or picky
Unsupervised or unable to comply with scheduled visits
The contralateral eye was judged to lose visual function
Other situations where the researcher judges that the patient is not suitable for inclusion