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临床试验/NCT05075226
NCT05075226Unknown不适用

Outcomes of Vivity EDOF IOL Implantation in Patients With Well Controlled OAG or OHT

Maisonneuve-Rosemont Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Binocular uncorrected visual acuity

研究概览

简要总结

Glaucoma is a progressive optic neuropathy that results in a loss of contrast sensitivity and visual field if not detected and treated. When glaucoma patients undergo cataract surgery, they are often not ideal candidates for many existing presbyopia correcting IOLs as they reduce contrast sensitivity because of the splitting of light and are more likely to have visual disturbances secondary to diffractive steps in the IOL design. This is largely because of a higher rate of ocular surface disease and meibomian gland dysfunction in this patient population due to the chronic utilization of topical drops. As a result of this, patients with glaucoma currently receive aspheric monofocal IOLs during cataract surgery, which are lenses with minimal loss of contrast sensitivity but only one point of focus (typically targeted for distance). This necessitates the use of glasses for near and intermediate vision and has an impact on quality of life for these patients.

The Vivity Extended Depth of Focus (EDOF) IOL is a new technology that maintains uncompromised distance vision and provides improved intermediate vision correction, reducing the need for glasses. This lens uses a new optical system with no diffractive steps in the IOL; trials in non-glaucomatous patients have shown the rate of visual aberrations to be comparable to an aspheric monofocal IOL which are currently the standard of care in patients with glaucoma. There is no published data on outcomes of this IOL in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). Studies are required to evaluate the clinical success of this new lens technology in glaucomatous patients. This will be the first study in Canada to report clinical outcomes of the Vivity IOL in this patient cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age greater than 18 years
  • Patients undergoing uncomplicated cataract surgery with IOL implantation
  • Patients with both eyes that calculate for IOL powers in the following ranges: 15-25D spherical power (for Vivity)
  • Patients possessing with-the-rule or against-the-rule astigmatism ≤2.50 D
  • Well controlled OAG or OHT defined as IOP less than or equal to 18mmHg
  • Mild to moderate glaucoma as defined by MD VF loss less than 12 dB and no VF defect within the central 5 degrees with 0dB or less than 15dB of both hemi-fields in the central 5 degrees

排除标准

  • Ocular comorbidity that might hamper post-operative visual acuity (ie. Macular degeneration, macular edema, uveitis, corneal dystrophy, diabetic retinopathy)
  • Ocular trauma or zonula instability
  • Previous refractive surgery
  • Irregular corneal astigmatism and keratoconus
  • Difficulties comprehending written or spoken English or French language
  • Patients with physical or intellectual disability
  • Patients unable to fixate
  • Patients with uncontrolled glaucoma or advanced glaucoma
  • Patients that are undergoing filtration or tube surgery or MIGS devices for glaucoma
  • Patients with previous filtration or tube surgery for glaucoma
  • Patients with unreliable biometry
  • Severe dry eye disease or ocular surface disease
  • Patients where Barrett Toric Calculator recommends T5 or higher toric IOL

结局指标

主要结局

Binocular uncorrected visual acuity

时间窗: 3 months

Binocular uncorrected visual acuities at near distance (40cm) will be measured

次要结局

  • IOP (mmHg at 1 day, 1 month and 3 months)(3 months)
  • Severity, frequency of bothersomeness of starbursts, haloes, and glare(3 months)
  • Spectacle independence(3 months)
  • IOP(1 month)
  • Mean refractive outcomes(3 months)
  • Refractive target accuracy(Approximate patient follow-up time is 4 months following phacoemulsification and insertion of the study lens in the second eye. Time in between eyes will be approximately 1-2 months.)
  • Contrast sensitivity(3 months)

研究者

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

Dr. Paul Harasymowycz

MD, Associate Professor

Maisonneuve-Rosemont Hospital

研究点 (1)

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