RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision
EMV
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2023
CompletedJune 14, 2022
June 1, 2022
12 months
May 2, 2022
June 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
contrast sensitivity
3-6 months
Study Arms (3)
Group 1
ACTIVE COMPARATORmonovision 0.25 - 0.74 D
Group 2
ACTIVE COMPARATORmonovision 0.75 -1.24 D
Group 3
ACTIVE COMPARATORmonovision 1.24 - 1.75
Interventions
Inducing different values of monovision
Eligibility Criteria
You may qualify if:
- \- bilateral senile cataract
You may not qualify if:
- corneal astigmatism greater than 0.75 diopters (D)
- difference in the planned dioptric value of intraocular lens (IOL) over 2 D (calculated for bilateral emetropia)
- perioperative complications not allowing proper implantation and centering of IOL in the lens bag
- time between surgeries of both eyes greater than 1 month
- eye disease, which could reduce visual acuity
- previous refractive surgeries
- systemic diseases that could affect postoperative visual acuity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Somich, s.r.o.lead
Study Sites (1)
Somich
Karlovy Vary, 36006, Czechia
Related Publications (7)
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.
PMID: 6706816BACKGROUNDRodov 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.
PMID: 31298723BACKGROUNDShen 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.
PMID: 28422087BACKGROUNDAbdelrazek 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.
PMID: 31802840BACKGROUNDWilkins 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.
PMID: 24070808BACKGROUNDde 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.
PMID: 23332253BACKGROUNDGreenstein 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.
PMID: 27792408RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eliska Studena, MSc
Somich, s.r.o.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of the department
Study Record Dates
First Submitted
May 2, 2022
First Posted
June 14, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2022
Study Completion
March 21, 2023
Last Updated
June 14, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
one researcher