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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal and Extended Depth-of-Focus intraocular lenses | Experimental | Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation |
|
| Monofocal intraocular Lenses | Active Comparator | Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs) | Device | IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| monocular vision measured with standard visual acuity charts | Uncorrected distance visual acuity and best corrected distance visual acuity | Measured first day, first week, first month, 3 months, and 6 months after cataract surgery |
| monocular vision measured with standard visual acuity charts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yinghong Ji, phD | Contact | 18917785069 | jiyh_eent@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yinghong Ji, phD | Eye Institute, Eye & ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28336402 | Background | 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. | |
| 30632671 |
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| Use Monofocal intraocular lenses(IOLs) | Device | Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS |
|
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 |
| Measured 1 month, 3 months, and 6 months after cataract surgery |
| Diopter measured by Phorometer | Important factor affecting the improvement of postoperative visual function | Measured 1 month, 3 months, and 6 months after cataract surgery |
| IOL rotation stability | 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°) | 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) | total aberration, total low-order aberration, and total high-order aberration | Measured 1 month, 3 months, and 6 months after cataract surgery |
| Contrast sensitivity measured by FACT chart | Provide accurate and comprehensive objective basis for the evaluation of visual function of cataract patients | Measured 6 months after cataract surgery |
| Binocular vision measured with standard visual acuity charts | 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. | Measured 6 months after cataract surgery |
| The rate of IOL dislocation | Effectiveness evaluation index | Measured 6 months after cataract surgery |
| Defocus Curve | Drawing Defocus Curve after taking the average of the data collected in each group of patients | Measured 6 months after cataract surgery |
| Postoperative satisfaction:Chinese version visual function index-12(VF-12-CN) | Questionnaire survey on patients' quality of life | Measured 6 months after cataract surgery |
| 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. |
| 25104599 | Background | 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. |
| 25986897 | Background | 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. |
| 3312575 | Background | 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. |
| 10201589 | Background | 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. |
| 25487425 | Background | 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. |
| 20692556 | Background | 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. |
| 29526338 | 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. |
| 27423631 | Background | 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. |
| 19996749 | Background | Naseri A, McLeod SD. Cataract surgery after refractive surgery. Curr Opin Ophthalmol. 2010 Jan;21(1):35-8. doi: 10.1097/ICU.0b013e328333e9ab. |
| 10646161 | Background | 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. |
| 14670401 | Background | 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. |
| 14670413 | Background | 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. |
| 20677729 | Background | 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. |
| 27006324 | Background | 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. |
| 26459996 | Background | 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. |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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