Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery
NCT ID: NCT04522427
Last Updated: 2020-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
114 participants
INTERVENTIONAL
2020-09-01
2022-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multifocal and Extended Depth-of-Focus intraocular lenses
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)
IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
Monofocal intraocular Lenses
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Use Monofocal intraocular lenses(IOLs)
Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS
Interventions
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Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)
IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
Use Monofocal intraocular lenses(IOLs)
Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Yinghong Ji, phD
Role: PRINCIPAL_INVESTIGATOR
Eye Institute, Eye & ENT Hospital of Fudan University
Locations
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Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wen D, McAlinden C, Flitcroft I, Tu R, Wang Q, Alio J, Marshall J, Huang Y, Song B, Hu L, Zhao Y, Zhu S, Gao R, Bao F, Yu A, Yu Y, Lian H, Huang J. Postoperative Efficacy, Predictability, Safety, and Visual Quality of Laser Corneal Refractive Surgery: A Network Meta-analysis. Am J Ophthalmol. 2017 Jun;178:65-78. doi: 10.1016/j.ajo.2017.03.013. Epub 2017 Mar 20.
Li M, Li M, Chen Y, Miao H, Yang D, Ni K, Zhou X. Five-year results of small incision lenticule extraction (SMILE) and femtosecond laser LASIK (FS-LASIK) for myopia. Acta Ophthalmol. 2019 May;97(3):e373-e380. doi: 10.1111/aos.14017. Epub 2019 Jan 11.
Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
Tang Y, Wang X, Wang J, Huang W, Gao Y, Luo Y, Lu Y. Prevalence and Causes of Visual Impairment in a Chinese Adult Population: The Taizhou Eye Study. Ophthalmology. 2015 Jul;122(7):1480-8. doi: 10.1016/j.ophtha.2015.03.022. Epub 2015 May 16.
Keates RH, Pearce JL, Schneider RT. Clinical results of the multifocal lens. J Cataract Refract Surg. 1987 Sep;13(5):557-60. doi: 10.1016/s0886-3350(87)80114-1.
Seitz B, Langenbucher A, Nguyen NX, Kus MM, Kuchle M. Underestimation of intraocular lens power for cataract surgery after myopic photorefractive keratectomy. Ophthalmology. 1999 Apr;106(4):693-702. doi: 10.1016/S0161-6420(99)90153-7.
Chan TC, Liu D, Yu M, Jhanji V. Longitudinal evaluation of posterior corneal elevation after laser refractive surgery using swept-source optical coherence tomography. Ophthalmology. 2015 Apr;122(4):687-92. doi: 10.1016/j.ophtha.2014.10.011. Epub 2014 Dec 6.
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.
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.
Alio JL, Abdelghany AA, Abdou AA, Maldonado MJ. Cataract surgery on the previous corneal refractive surgery patient. Surv Ophthalmol. 2016 Nov-Dec;61(6):769-777. doi: 10.1016/j.survophthal.2016.07.001. Epub 2016 Jul 15.
Naseri A, McLeod SD. Cataract surgery after refractive surgery. Curr Opin Ophthalmol. 2010 Jan;21(1):35-8. doi: 10.1097/ICU.0b013e328333e9ab.
Gimbel H, Sun R, Kaye GB. Refractive error in cataract surgery after previous refractive surgery. J Cataract Refract Surg. 2000 Jan;26(1):142-4. doi: 10.1016/s0886-3350(99)00327-2.
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.
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.
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.
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.
Wang L, Tang M, Huang D, Weikert MP, Koch DD. Comparison of Newer Intraocular Lens Power Calculation Methods for Eyes after Corneal Refractive Surgery. Ophthalmology. 2015 Dec;122(12):2443-9. doi: 10.1016/j.ophtha.2015.08.037. Epub 2015 Oct 14.
Other Identifiers
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Yinghong Ji
Identifier Type: -
Identifier Source: org_study_id
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