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临床试验/NCT07008768
NCT07008768已完成不适用

Visual Outcome After Implantation of Three Different Presbyopia-correcting IOLs and Monofocal IOL

University Eye Hospital Svjetlost2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
131
试验地点
2
主要终点
Uncorrected and Corrected Visual Acuity changes for distance, intermediate, and near in all four groups during the follow up

研究概览

简要总结

The objective of this study was to evaluate the effect of intraocular lens (IOL) selection on visual acuity and refractive outcomes, to assess the impact of IOL type on postoperative contrast sensitivity, and to investigate whether IOL choice influences the induction and dynamics of higher-order ocular aberrations following cataract surgery/refractive lens exchange surgery in hyperopic patients.

详细描述

A prospective randomized interventional clinical study was conducted in its entirety at the Department of Refractive Surgery, University Eye Hospital Svjetlost, Zagreb, Croatia. Participant enrolment occurred between January 1, 2018, and October 31, 2020. Each participant was followed prospectively for a period of 12 months.

The study was designed to include 4 groups, each comprising 50 participants. Eligible participants were those aged 45 years or older and present with hyperopia ranging from +0.50 dioptres (D) to +5.00 D, and astigmatism of up to +1.00 D. Participants with refractive errors must exhibit a best-corrected visual acuity (BCVA) of ≥0.05 Logarithm of the Minimum Angle of Resolution (LogMAR). For those with cataracts, inclusion requires a BCVA of ≥0.7 LogMAR, contingent upon cataract severity. Participants with BCVA <0.05 LogMAR were enrolled only after the exclusion of low vision, as confirmed by prior ophthalmological records.

All patients underwent a comprehensive preoperative ophthalmologic evaluation. This included slit-lamp bio microscopy of the anterior segment and dilated fundus examination. Uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), as well as manifest and cycloplegic refractions were recorded. Corneal tomography was performed to assess the topography of both the anterior and posterior corneal surfaces, as well as corneal thickness. Wavefront aberrometry (Luneau Visionix L80 Wave+, Visionix, Prunay-le-Gillon, France), was conducted to evaluate higher-order aberrations. Pupil size was measured under photopic, mesopic, and scotopic conditions using a pupillometer (Peramis, CSO, Italy). Specular microscopy (Perseus specular microscope, CSO, Firenze, Italy), was employed to determine corneal endothelial cell density. Additional assessments included determination of ocular dominance, evaluation of ocular motility, and assessment of tear film stability using the Schirmer test and Tear Break-Up Time (TBUT) test. Contrast sensitivity (CS) at 10% and 25% illumination was also measured.

Phacoemulsification was performed using the Infinity Vision System (Abbott Medical Optics, WhiteStar Signature Phacoemulsification System). Surgical parameters, including phaco power, vacuum level, pulse mode, oscillation, and infusion bottle height, were adjusted according to the specific phase of the procedure. All surgeries were performed by a single experienced surgeon employing a standardized micro coaxial technique. Corneal incisions measuring 2.7 mm were created along the steepest meridian; in rare cases where intraoperative challenges were encountered, the incision was extended.

Following successful completion of anterior capsulorhexis and lens phacoemulsification, a foldable intraocular lens (IOL) was implanted into the capsular bag via the main incision using the Acrijet Blue injector (VSY Biotechnology, Amsterdam, Netherlands). Residual viscoelastic material was thoroughly removed by irrigation and aspiration. All corneal incisions were self-sealing and did not require suturing. At the conclusion of the procedure, an antibiotic drop was instilled intraocularly, and antibiotic ointment was applied to the conjunctival sac. Maxitrol eyedrops (Alcon, Fort Worth, Texas), a neomycin, polymyxin B sulphates, and dexamethasone ophthalmic suspension were prescribed for application after the surgery. At first postoperative day drops were administered every hour, then four times per days in first postoperative week, and then gradually tapered for next three weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Age of ≥ 45 years
  • Hyperopic correction ranging from +0.50 D to +5.00 D, and astigmatism of up to +1.00 D
  • Best corrected visual acuity of ≥0.05 LogMAR

排除标准

  • Previously performed eye surgical procedures or eye injuries
  • Fuchs' endothelial dystrophy or other corneal diseases (corneal degeneration and dystrophy)
  • Zonular weakness or subluxated lens
  • Systemic autoimmune and rheumatic disease
  • Insulin dependent diabetes

结局指标

主要结局

Uncorrected and Corrected Visual Acuity changes for distance, intermediate, and near in all four groups during the follow up

时间窗: 12 months

To evaluate differences in uncorrected distance visual acuity (UDVA); corrected distance visual acuity (CDVA); uncorrected intermediate visual acuity (UIVA); corrected intermediate visual acuity (CIVA); uncorrected near visual acuity (UNVA), and corrected near visual acuity (CNVA) following the implantation of three types of multifocal intraocular lenses (IOLs) and one monofocal IOL (serving as the control group), the mean values of visual acuity parameters were compared across all four IOL groups at each postoperative measurement time point.

Higher-order aberration changes in all four groups during the follow up

时间窗: 12 months

The values of coma aberration were defined as the square root (Root mean square - RMS) of the sum of the squares of the coefficients Z-13 and Z13, while the amount of spherical aberration is defined as the value of the Z04 coefficient.

Contrast sensitivity changes at 25% and 10% illumination in all four groups during the follow up

时间窗: 12 months

Contrast sensitivity was measured monocularly on a computerized screen in a lighted room at 85cd/m2. Sloan letters were projected onto the screen at 0.1 LogMAR, at the illuminances of 25% and 10%. Visual acuity was recorded at logMAR where the patient was able to read all letters.

次要结局

未报告次要终点

研究者

发起方
University Eye Hospital Svjetlost
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mateja Jagic

MD, Principal Investigator

University Eye Hospital Svjetlost

研究点 (2)

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