NCT05417633|Unknown
RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision
EMV
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EMV
Sponsor study identifier
interventional
60
1 country
1
Study Start
January 1, 2022
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 21, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Aim:To determine the effectiveness and subjective satisfaction of patients with bilateral cataract surgery and implantation of intraocular lens (IOL) RayOne EMV with enhanced optic, using different degrees of mini-monovision (up to 0.74, between 0.75 -1.24 and 1.25-1.75). To compare individual groups between themselves . In particular, we would like to compare the independence of spectacle correction when looking into the distance, at medium distance and at reading distance.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 21, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2022
Actual (reported)May 2, 2022
Actual (reported)June 14, 2022
Actual (reported)December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 21, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
visual acuity (VA)
uncorrected for distance (UDVA), intermediate distance (UIVA), near (UNVA) corrected for distance (CDVA), intermediate distance (CIVA), near (CNVA)
3-6 months
sS Subjective satisfaction
questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5
3-6 months
contrast sensitivity
3-6 months
monovision 0.25 - 0.74 D
monovision 0.75 -1.24 D
monovision 1.24 - 1.75
Inducing different values of monovision
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Somich
Karlovy Vary, 36006, Czechia
Boerner CF, Thrasher BH. Results of monovision correction in bilateral pseudophakes. J Am Intraocul Implant Soc. 1984 Winter;10(1):49-50. doi: 10.1016/s0146-2776(84)80077-4.
Rodov L, Reitblat O, Levy A, Assia EI, Kleinmann G. Visual Outcomes and Patient Satisfaction for Trifocal, Extended Depth of Focus and Monofocal Intraocular Lenses. J Refract Surg. 2019 Jul 1;35(7):434-440. doi: 10.3928/1081597X-20190618-01.
Eliska Studena, MSc
Somich, s.r.o.
First Submitted
May 2, 2022
First Posted
June 14, 2022
Study Start
January 1, 2022
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)Contact the study team to confirm eligibility.
Shen Z, Lin Y, Zhu Y, Liu X, Yan J, Yao K. Clinical comparison of patient outcomes following implantation of trifocal or bifocal intraocular lenses: a systematic review and meta-analysis. Sci Rep. 2017 Mar 28;7:45337. doi: 10.1038/srep45337.
Abdelrazek Hafez T, Helaly HA. Spectacle Independence And Patient Satisfaction With Pseudophakic Mini-Monovision Using Aberration-Free Intraocular Lens. Clin Ophthalmol. 2019 Oct 31;13:2111-2117. doi: 10.2147/OPTH.S215229. eCollection 2019.
Wilkins MR, Allan BD, Rubin GS, Findl O, Hollick EJ, Bunce C, Xing W; Moorfields IOL Study Group. Randomized trial of multifocal intraocular lenses versus monovision after bilateral cataract surgery. Ophthalmology. 2013 Dec;120(12):2449-2455.e1. doi: 10.1016/j.ophtha.2013.07.048. Epub 2013 Sep 23.
de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.
Greenstein S, Pineda R 2nd. The Quest for Spectacle Independence: A Comparison of Multifocal Intraocular Lens Implants and Pseudophakic Monovision for Patients with Presbyopia. Semin Ophthalmol. 2017;32(1):111-115. doi: 10.1080/08820538.2016.1228400. Epub 2016 Oct 28.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 21, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 14, 2022
Record last verified: 2022-06
one researcher
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