跳至主要内容
临床试验/CTRI/2023/06/053566
CTRI/2023/06/053566已完成不适用

To assess the safety and efficacy of Novel Cannulated Suture Thread Device for Easy Scleral Fixation of a Multipiece Intraocular Lens (S-FIX)

Aurolab1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月13日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
Aurolab
入组人数
30
试验地点
1
主要终点
percentage of patients showing 1-2 lines of improvement in BCVA chi square test

研究概览

简要总结

Scleral fixation of a multipiece intraocular lens (SFIOL) is an established modality for surgical correction of aphakia. The two most crucial steps of SFIOL surgery are exteriorization of the haptic and fixation of the same intrasclerally. Various techniques have been described in the literature to constantly simplify these steps. Most techniques differ in the way the haptics are fixed. Appropriate and adequate fixation of the haptic of a multipiece intraocular lens inside the scleral groove is a key component in SFIOL surgeries. Conventional methods of fixing the haptic require either specialized forceps, additional surgical steps like scleral flap creation or additional consumables like bio fibrin glue. Here, we describe a novel cannulated suture thread device (S-FIX) for easy scleral fixation of a multipiece intraocular lens. The S-FIX technique does not require conjunctival peritomy, specialized vitreo-retinal forceps, flap, flange or glue. Aphakic patients who require SFIOL implantation will be recruited. after obtaining consent the SFIOL surgery will be done using S-Fix device. All intra-operative complications will be noted. Post-operative follow-up will be on day 1, day 14, and day 45. Post operative follow-up include Refraction, specular microscopy and OCT. ASOCT will be done on POD 45 and IOL tilt will be measured using image J software. All post operative complications will be noted.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • a) All patients with aphakia who require SFIOL implantation b) Both post cataract surgery and post trauma aphakia are included.

排除标准

  • a) History of glaucoma or uveitis b) Any other retinal pathology other than dislocated nucleus or intraocular lens c) Penetrating keratoplasty and any other combined procedures d) Monocular patients e) Pediatric age group less than 18 years of age f) Patients who are not willing to consent for the procedure.

结局指标

主要结局

percentage of patients showing 1-2 lines of improvement in BCVA chi square test

时间窗: 45 days

次要结局

  • -Intraoperative and post-operative complications-Percentage (Categorical)(-IOL tilt assessment-percentage of eyes with tilt and mean IOL tilt in degree, continuous variable)

研究者

发起方
Aurolab
申办方类型
Other [Ophthalmic device and drug manufacturing unit ]

研究点 (1)

Loading locations...

相似试验