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临床试验/NCT05417633
NCT05417633Unknown不适用

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

Somich, s.r.o.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
visual acuity (VA)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • bilateral senile cataract

排除标准

  • 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

结局指标

主要结局

visual acuity (VA)

时间窗: 3-6 months

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

sS Subjective satisfaction

时间窗: 3-6 months

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

次要结局

  • contrast sensitivity(3-6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomas Benda, MD, FEBO

head of the department

Somich, s.r.o.

研究点 (2)

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