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
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.
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:
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
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.
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- bilateral senile cataract
Exclusion Criteria:
monovision 0.25 - 0.74 D
Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
monovision 0.75 -1.24 D
Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
monovision 1.24 - 1.75
Procedure: intraocular lens - RayOne EMV (Rayner Surgical GmbH,Berlin, Deutschland)
Inducing different values of monovision
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
sS Subjective satisfaction
questionnaire of subjective satisfaction, dependence on glasses, incidence of secondary visual phenomena - scale 1-5
Time frame: 3-6 months
contrast sensitivity
Glaretester
Time frame: 3-6 months
Plan to share: No — one researcher
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Somich, s.r.o.