跳至主要内容
临床试验/CTRI/2016/04/006806
CTRI/2016/04/006806已完成不适用

Are steroids required to control post-operative inflammation after uncomplicated phacoemulsification surgery?

The Calcutta Medical Research Institute1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年5月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
Anterior segment inflammation

研究概览

简要总结

Rationale andbackground

It is standard practice toput patients on tapering doses of topical steroids after all forms of cataractsurgeries. It has been our experience that we can often switch patients toNSAID drops after a week of steroid-antibiotic drops after uncomplicatedcataract surgery. This is essentially done to avoid side-effects of topicalsteroids like secondary glaucoma, rebound iritis etc. In our practice we havebeen replacing steroids with NSAIDs primarily to avoid rebound iritis inpatients who had this complication in the first eye. It then dawned upon usthat topical NSAIDs could have an extended role in post-cataract surgeryscenario and we may be able to avoid topical steroids altogether in thiscontext. This study is proposed to establish as evidence that modern NSAIDs maysafely replace steroids one week after uncomplicated cataract surgeries.

This study is a prelude toanother study which will question whether steroids are required even during thefirst week after clean Phacoemulsification.

Relevant data isnot available for Indian population – which is also an incentive for the study.

Aims andobjectives

Primaryobjective of the study is to answer the question: “Are steroids required to controlpost-operative inflammation after uncomplicated phacoemulsification surgery?â€

We will also becollecting OCT data to look at preliminary evidence as to whether the incidenceof CME is different between the two broad treatment groups – those with steroidfollowed by NSAID and those treated with steroids throughout the course offollow up.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Uncomplicated cases of Phacoemulsification with IOL implantation.
  • Uncomplicated being defined as a.No capsular dehiscence b.Placement of single piece foldable IOL in the capsular bag c.No sutures applied 2.Includes surgeries where there have been iris handling/trauma (e.g. due to IFIS) or where iris retractors were used 3.Includes surgeries done under GA/Peri-bulbar block/Topical anaesthesia 4.Includes per-operative use of intra-cameral adrenaline and/or trypan blue.

排除标准

  • 1.Presence of intra-ocular inflammation.
  • 2.History of uveitis – anterior/posterior/pan.
  • 3.Rubeosis iridis.
  • 4.Diabetic eye disease including any diabetic retinopathy (even background).
  • 5.History of herpes simplex/HZO (as there may be corneal anaesthesia and subsequent epithelial problems with NSAID therapy).
  • 6.Glaucoma patients on prostaglandin analogue medication.
  • 7.Ocular surface damage secondary to dry eye disease involving staining of the cornea.
  • Conjunctival staining alone is not an exclusion criteria.
  • 8.Use of per-operative intra-cameral antibiotics and/or lignocaine 9.Any intraocular procedure in the last 3 months.
  • 10.Lost to follow up.

结局指标

主要结局

Anterior segment inflammation

时间窗: 1,3 and 5 weeks post surgery

Pain

时间窗: 1,3 and 5 weeks post surgery

次要结局

  • Cystiod macular oedema(1,3 and 5 weeks post surgery)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

Loading locations...

相似试验