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RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision (EMV)

Primary Purpose

Cataract Senile, Presbyopia

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
Sponsored by
Somich, s.r.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Senile focused on measuring Intraocular lens enhanced, minimonovision

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- bilateral senile cataract

Exclusion Criteria:

  • 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

Sites / Locations

  • SomichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

monovision 0.25 - 0.74 D

monovision 0.75 -1.24 D

monovision 1.24 - 1.75

Outcomes

Primary Outcome Measures

visual acuity (VA)
uncorrected for distance (UDVA), intermediate distance (UIVA), near (UNVA) corrected for distance (CDVA), intermediate distance (CIVA), near (CNVA)
sS Subjective satisfaction
questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5

Secondary Outcome Measures

contrast sensitivity
Glaretester

Full Information

First Posted
May 2, 2022
Last Updated
June 9, 2022
Sponsor
Somich, s.r.o.
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1. Study Identification

Unique Protocol Identification Number
NCT05417633
Brief Title
RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision
Acronym
EMV
Official Title
RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somich, s.r.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Purpose: 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 themselve Preoperative examination - Eye dominance - hole in card method Argos optical biometrics (Movu, Inc., CA, U.S.) Barrett's formulas (Barrett universal II) will be used to calculate the optimal IOL. A RayOne EMV lens with a planned postoperative spherical equivalent (SE) of -0.25 to 0.25 will be implanted in the dominant eye. A lens with a planned SE of -0.25 to -0.74 will be implanted in the non-dominant eye in the first group, -0.75 to -1.24 in the second group and -1.25 to -1.75 in the third group. Surgery Standard course of surgery, corneal incision at No. 12, combination of topical and intracameral anesthesia, implantation of IOL into the capsular bag, primary posterior capsulorhexis (PPCCC) performed after implantation. Postoperative evaluation In addition to standard postoperative examinations (anterior segment condition, intraocular pressure), the resulting refraction will be monitored postoperatively (3 and 6 months after second eye surgery) using an autorefractometer. Uncorrected (UCVA) and corrected distance visual acuity (DCVA) will be examined using projection optotypes. Uncorrected (UIVA) medium distance visual acuity (60 cm) and uncorrected (UNVA) and corrected (CNVA) near visual acuity (30 cm) using standardized EDTRS reading tables. All values of visual acuity will be examined monocularly and binocularly (bUCVA, bDCVA, bUNVA, bCNVA, bUIVA). Visual acuity values will be expressed in logMAR. Binocular Contrast sensitivity will be examined using a Glaretester CGT 1000 instrument (Takagi, Seiko Co. Ltd., Nagano, Japan) at a distance (test distance) of 30 cm, 60 cm 5 m. (day), type of glare, low glare, presentation duration of test target 0.8 s, presentation interval of test target 2 s. The resulting values will be expressed numerically and graphically in comparison with the standard . Patients will be asked to complete questionnaires: the occurrence of secondary visual symptoms (eg halo - ring around the light source, glare - fog around the light source and starbursts - rays around the light source). Patients will rate these side effects on a scale of 0 - 5 (0 - none, 1 - very mild, 2 - mild 3 - moderate 4 - severe 5 - very severe). for independence on glasses a) at close range b) at medium distance c) at a distance. Patients rate on a scale of 1 - 5 (1 - never uses glasses, 2 - exceptionally uses glasses 3 - occasionally uses glasses 4 - often uses glasses 5 - always uses glasses). Satisfaction with the result of the operation. Patients rate on a scale of 1 - 5 (1 - very satisfied 2 - rather satisfied 3 - neutral 4 - rather dissatisfied 5 - very dissatisfied). 6. Statistical analysis - descriptive data describing the group of patients and visual, refractive results and contrast sensitivity and questionnaires will be processed. The Wilcoxon signed-rank test will be used to compare preoperative and postoperative visual acuity. The Mann-Whitney U test will be used to compare visual symptoms and patient satisfaction in each group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile, Presbyopia
Keywords
Intraocular lens enhanced, minimonovision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
monovision 0.25 - 0.74 D
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
monovision 0.75 -1.24 D
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
monovision 1.24 - 1.75
Intervention Type
Procedure
Intervention Name(s)
intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
Intervention Description
Inducing different values of monovision
Primary Outcome Measure Information:
Title
visual acuity (VA)
Description
uncorrected for distance (UDVA), intermediate distance (UIVA), near (UNVA) corrected for distance (CDVA), intermediate distance (CIVA), near (CNVA)
Time Frame
3-6 months
Title
sS Subjective satisfaction
Description
questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
contrast sensitivity
Description
Glaretester
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - bilateral senile cataract Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Studeny, MD
Phone
00420775555342
Email
studenypavel@seznam.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliska Studena, MSc
Organizational Affiliation
Somich, s.r.o.
Official's Role
Study Director
Facility Information:
Facility Name
Somich
City
karlovy Vary
ZIP/Postal Code
36006
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Studeny, MD
Phone
00420775555342
Email
studenypavel@seznam.cz

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
one researcher
Citations:
PubMed Identifier
6706816
Citation
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.
Results Reference
background
PubMed Identifier
31298723
Citation
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.
Results Reference
background
PubMed Identifier
28422087
Citation
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.
Results Reference
background
PubMed Identifier
31802840
Citation
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.
Results Reference
background
PubMed Identifier
24070808
Citation
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.
Results Reference
background
PubMed Identifier
23332253
Citation
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.
Results Reference
background
PubMed Identifier
27792408
Citation
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.
Results Reference
result

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RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision

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