跳至主要内容
临床试验/CTRI/2023/03/050397
CTRI/2023/03/050397招募中4 期

A prospective, controlled randomized, comparative, single center, clinical study to evaluate performance and safety of implanted Capsular Tension Ring (CTR) and CTR delivery system.

Grewal Eye Institute0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Patients older than 12 years
  • 2. Normal fundus examination
  • 3. Patients for whom phacoemulsification is required of cataract
  • 4. Patients with axial length >28 mm, or more than 3 months had
  • passed since Pars plana vitrectomy (PPV)
  • 5. Patients with weak zonules along with any of this following
  • Inadequate zonular support
  • Patients with the pseudo-exfoliation syndrome
  • Trauma causing zonular dialysis
  • Phacodonesis
  • 6. Patients who are eligible for phacoemulsification alone or
  • with CTR implants
  • 7. Patients who are eligible for phacoemulsification alone or
  • with CTR implants
  • 8. Patient willing to participate and sign informed consent forms.
  • 9. Female participants of child bearing potential and male
  • participants whose partner is of child bearing potential
  • must be willing to ensure that they or their partner use
  • effective contraception during the study

排除标准

  • 1.Presence of a torn or compromised capsular
  • bag or significant, progressive
  • pseudoexfoliation
  • 2.Patients with retinitis pigmentosa,
  • trauma, other intraocular surgeries than
  • PPV, or connective tissue disorders
  • 3.Patients with chronic uveitis
  • 4.Patients with progressive eye disease
  • (e.g. diabetic retinopathy, uncontrolled
  • 5.Patients with preoperative complications
  • prior to cataract surgery (e.g. vitreous
  • body prolapse, haemorrhage)
  • 6.Patients with perforated or damaged
  • 7.Patients with zonular damage larger than 4
  • clock hours
  • 8.Zonular rupture >90º
  • 9.Pregnancy (as stated by patient) and
  • 10.Patients with concurrent participation in
  • another drug or medical device clinical

研究者

发起方
Grewal Eye Institute

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