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Status unknownNCT05417633EMVUpdated Jun 14, 2022

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

An interventional study of intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland) in Cataract Senile and Presbyopia, sponsored by Somich, s.r.o.. Status unknown at 1 site in Czechia. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Somich, s.r.o. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2022, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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:

  1. 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).
  2. 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).
  3. 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

02

Conditions studied

  • Cataract Senile
  • Presbyopia

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Keywords

  • Intraocular lens enhanced
  • minimonovision
03

In context

Presbyopia

330 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 271 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Somich, s.r.o. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- bilateral senile cataract

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group 1

    monovision 0.25 - 0.74 D

    Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)

  • Active comparator
    Group 2

    monovision 0.75 -1.24 D

    Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)

  • Active comparator
    Group 3

    monovision 1.24 - 1.75

    Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)

Interventions

  • Procedureintraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)

    Inducing different values of monovision

06

What researchers measure

Primary outcomes

  1. visual acuity (VA)

    uncorrected for distance (UDVA), intermediate distance (UIVA), near (UNVA) corrected for distance (CDVA), intermediate distance (CIVA), near (CNVA)

    Time frame: 3-6 months

  2. sS Subjective satisfaction

    questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5

    Time frame: 3-6 months

Secondary outcomes

  1. contrast sensitivity

    Glaretester

    Time frame: 3-6 months

07

Study locations

1 of 1 sites recruiting
  • Somich
    Karlovy Vary, 36006, Czechia
    Recruiting
08

References and documents

Publications

  • 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. PubMed 6706816 ↗
  • 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. PubMed 31298723 ↗
  • 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. PubMed 28422087 ↗
  • 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. PubMed 31802840 ↗
  • 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. PubMed 24070808 ↗
  • 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. PubMed 23332253 ↗
  • 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. PubMed 27792408 ↗

Individual participant data

Plan to share: No — one researcher

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05417633
Lead sponsor
Somich, s.r.o.
Responsible party
Tomas Benda, MD, FEBO (head of the department, Somich, s.r.o.) — Principal investigator
First posted
Jun 14, 2022
Start date
Jan 1, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Mar 21, 2023 (estimated)
Last update
Jun 14, 2022

Study contacts

Pavel Studeny, MD
Contact
studenypavel@seznam.cz
00420775555342
Eliska Studena, MSc
study director · Somich, s.r.o.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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