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临床试验/CTRI/2025/04/083817
CTRI/2025/04/083817尚未招募4 期

Visual and functional outcomes after bilateral implantation of an Enhanced monofocal Intraocular Lens targeted for Mini-Monovision

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Uncorrected Distant Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA) at 40, 60, 80cm and Uncorrected Near Visual Acuity

研究概览

简要总结

This study aims to assess the clinical outcomes, the level of spectacle independence, and patient satisfaction after bilateral implantation of an enhanced depth of focus (EDOF) IOL-Hoya Impress EDOF targeted for mini-monovision. The Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) is an enhanced monofocal IOL made from glistening-free hydrophobic acrylate. Its aspheric optic design extends the depth of field, particularly improving vision in the intermediate range. Mini-monovision is a vision correction technique commonly used in cataract and refractive surgeries to reduce dependency on glasses, particularly for patients who want better near and intermediate vision without compromising distance vision. In this approach, one eye (usually the dominant eye) is optimized for distance vision, while the other eye is set for intermediate or near vision by using different intraocular lenses (IOLs) or modifying the prescription.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts, Posterior subcapsular cataract
  • Age >35 years
  • Corneal astigmatism less than 0.75D
  • IOL power between +10D to +30D
  • In the bag IOL implantation.

排除标准

  • Eyes with corneal astigmatism >0.75 D
  • Hypermature/morgagnian/intumescent and brunescent cataracts >NS 4
  • Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts <1500cells/ mm2
  • Pupillary abnormalities
  • History of glaucoma or intraocular inflammation
  • Macular disease or retinopathy, neuro-ophthalmic diseases, active infections, previous ocular surgery of any kind, any other ocular pathology.
  • Intraoperative or postoperative complications.

结局指标

主要结局

Uncorrected Distant Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA) at 40, 60, 80cm and Uncorrected Near Visual Acuity

时间窗: Post operative Day 1, 2 weeks and 3 months

次要结局

  • Contrast sensitivity, Objective scatter index, Defocus curves & Aberrations(Post operative Day 1, 2 weeks & 3 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

SUPRIYA SRIGANESH

Nethradhama Superspeciality Eye Hopsital

研究点 (1)

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