Cataract SenileEMVNCT05417633
RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision
A study testing intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland) in people with Cataract Senile and Presbyopia, run by Somich, s.r.o. at 1 site in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract Senile, Presbyopia
- What is being tested?
- intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2022to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral senile cataract
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Somich
Karlovy Vary, 36006
Pavel Studeny, MD, 00420775555342, studenypavel@seznam.cz
About this study
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:
- 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).
- 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
- Conditions
- Cataract Senile, Presbyopia
- Being tested
- intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
- Keywords
- Intraocular lens enhanced, minimonovision
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)Procedure or surgery
Inducing different values of monovision
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | monovision 0.25 - 0.74 D Receives: Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland) |
| Group 2 | Active comparator | monovision 0.75 -1.24 D Receives: Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland) |
| Group 3 | Active comparator | monovision 1.24 - 1.75 Receives: Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity (VA)
uncorrected for distance (UDVA), intermediate distance (UIVA), near (UNVA) corrected for distance (CDVA), intermediate distance (CIVA), near (CNVA)
Measured: 3-6 months
sS Subjective satisfaction
questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5
Measured: 3-6 months
Secondary outcomes (1)
contrast sensitivity
Glaretester
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion21 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cataract SenileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somich, s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Benda, MD, FEBO, Somich, s.r.o.
- Investigators
- Eliska Studena, MSc, Study director, Somich, s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417633
- Sponsor's protocol ID
- Somich
- Acronym
- EMV
- Status last verified
- Jun 2022
- First submitted
- 2 May 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: one researcher
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 6706816Rodov 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 31298723Shen 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 28422087Abdelrazek 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 31802840Wilkins 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 24070808de 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 23332253Greenstein 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RayOne EMV Mini-monovision - Efficiency and Safety of 3 Grades of Mini-monovision
- ClinicalTrials.gov ID
- NCT05417633
- Acronym / sponsor ID
- EMV / Somich
- Conditions
- Cataract Senile, Presbyopia
- Keywords
- Intraocular lens enhanced, minimonovision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Somich, s.r.o.University, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 21 Mar 2023 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)monovision 0.25 - 0.74 D |
| Group 2 | Active comparator | Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)monovision 0.75 -1.24 D |
| Group 3 | Active comparator | Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)monovision 1.24 - 1.75 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral senile cataract
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)Inducing different values of monovision | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
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)
sS Subjective satisfaction
Time frame: 3-6 months
questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5
1 secondary outcome
contrast sensitivity
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Background: PubMed 6706816Boerner 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.
- Background: PubMed 31298723Rodov 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.
- Background: PubMed 28422087Shen 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.
- Background: PubMed 31802840Abdelrazek 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.
- Background: PubMed 24070808Wilkins 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.
- Background: PubMed 23332253de 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 publication: PubMed 27792408Greenstein 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.
- Individual participant dataSharing planned: No. one researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliska Studena, MSc study director
Somich, s.r.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland) in people with Cataract Senile and Presbyopia, run by Somich, s.r.o. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel Studeny, MD (00420775555342, studenypavel@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (VA) (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417633, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.