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

NCT04522427 | Unknown

• 1 other identifier: Yinghong Ji
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia

Keywords

Post-corneal Refractive Surgery; Presbyopia-correcting IOL; Cataract; Efficiency; Safety

Outcome Measures

Primary Outcomes (3)

• Postoperative UDVA measured with standard visual acuity charts

  postoperative uncorrected distance visual acuity(UDVA)

  Measured 3 months after cataract surgery

• Postoperative UIVA measured with standard visual acuity charts

  Postoperative uncorrected intermediate visual acuity(UIVA)

  Measured 3 months after cataract surgery

• Postoperative UNVA measured with standard visual acuity charts

  Postoperative uncorrected near visual acuity(UNVA)

  Measured 3 months after cataract surgery

Secondary Outcomes (10)

• monocular vision measured with standard visual acuity charts

  Measured first day, first week, first month, 3 months, and 6 months after cataract surgery

• monocular vision measured with standard visual acuity charts

  Measured 1 month, 3 months, and 6 months after cataract surgery

• Diopter measured by Phorometer

  Measured 1 month, 3 months, and 6 months after cataract surgery

• IOL rotation stability

  Measured first day, first week, first month, 3 months, and 6 months after cataract surgery

• Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX)

  Measured 1 month, 3 months, and 6 months after cataract surgery

Study Arms (2)

Multifocal and Extended Depth-of-Focus intraocular lenses

EXPERIMENTAL

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

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

Monofocal intraocular Lenses

ACTIVE COMPARATOR

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

Device: Use Monofocal intraocular lenses(IOLs)

Interventions

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

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

Multifocal and Extended Depth-of-Focus intraocular lenses

Use Monofocal intraocular lenses(IOLs) DEVICE

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

Monofocal intraocular Lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (17)

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• Wang L, Hill WE, Koch DD. Evaluation of intraocular lens power prediction methods using the American Society of Cataract and Refractive Surgeons Post-Keratorefractive Intraocular Lens Power Calculator. J Cataract Refract Surg. 2010 Sep;36(9):1466-73. doi: 10.1016/j.jcrs.2010.03.044.

  PMID: 20692556 BACKGROUND

• Ferreira TB, Pinheiro J, Zabala L, Ribeiro FJ. Comparative analysis of clinical outcomes of a monofocal and an extended-range-of-vision intraocular lens in eyes with previous myopic laser in situ keratomileusis. J Cataract Refract Surg. 2018 Feb;44(2):149-155. doi: 10.1016/j.jcrs.2017.11.007. Epub 2018 Mar 8.

  PMID: 29526338 BACKGROUND

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• Koch DD, Wang L. Calculating IOL power in eyes that have had refractive surgery. J Cataract Refract Surg. 2003 Nov;29(11):2039-42. doi: 10.1016/j.jcrs.2003.10.009. No abstract available.

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• Aramberri J. Intraocular lens power calculation after corneal refractive surgery: double-K method. J Cataract Refract Surg. 2003 Nov;29(11):2063-8. doi: 10.1016/s0886-3350(03)00957-x.

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• Tang M, Li Y, Huang D. An intraocular lens power calculation formula based on optical coherence tomography: a pilot study. J Refract Surg. 2010 Jun;26(6):430-7. doi: 10.3928/1081597X-20090710-02. Epub 2010 Jun 17.

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• Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg. 2016 Mar;42(3):363-9. doi: 10.1016/j.jcrs.2015.11.039. Epub 2016 Mar 19.

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MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Yinghong Ji, phD

  Eye Institute, Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinghong Ji, phD

CONTACT

18917785069; jiyh_eent@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 21, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2022
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)