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

June 9, 2022 updated by: Tomas Benda, MD, FEBO, Somich, s.r.o.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • karlovy Vary, Czechia, 36006
        • Recruiting
        • Somich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
monovision 0.25 - 0.74 D
Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
Inducing different values of monovision
ACTIVE_COMPARATOR: Group 2
monovision 0.75 -1.24 D
Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
Inducing different values of monovision
ACTIVE_COMPARATOR: Group 3
monovision 1.24 - 1.75
Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
Inducing different values of monovision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity (VA)
Time Frame: 3-6 months
uncorrected for distance (UDVA), intermediate distance (UIVA), near (UNVA) corrected for distance (CDVA), intermediate distance (CIVA), near (CNVA)
3-6 months
sS Subjective satisfaction
Time Frame: 3-6 months
questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
contrast sensitivity
Time Frame: 3-6 months
Glaretester
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somich, s.r.o.

Investigators

  • Study Director: Eliska Studena, MSc, Somich, s.r.o.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

March 21, 2023

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (ACTUAL)

June 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Somich

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

one researcher

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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