跳至主要内容
临床试验/CTRI/2024/02/062394
CTRI/2024/02/062394尚未招募2 期

A Small incision cataract surgery trabeculectomy with phacoemulsification trabeculectomy - a randomised controlled trial

未提供1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
72
试验地点
1
主要终点
to analyse visual field outcome and intraocular pressure preoperative and postoperative in both surgeries

研究概览

简要总结

Glaucoma and cataract follow a silent and highly variable natural course and the most common causes of visual handicap in senescence. the presence of cataract can affect the ability to assess glaucoma progression, and cataract extraction affects intraocular pressure as well as effectiveness of glaucoma surgery. Combined procedures reduces the hospital stay and health expenditure of the individual. As limited number of studies are being available on the comparison between SICS Trabeculectomy vs Phacoemulsification trabeculectomy on the patients with the coexisting cataract and open angle glaucoma Hence, to aid in early detection and treatment & to fill the vaccum of knowledge this study is being conducted,All patients coming to Eye OPD of age more than 50 years (RMCH) with coexisting cataract and glaucoma at fulfilling the inclusion and exclusion criteria.Size is statistically calculated by using the software Power and sample size program. The calculated sample size is 36 in each group. A total of 72 patients will be taken. After taking approval from the Institutional Ethical Committee, this study will be conducted by recruiting the patients, qualifying the inclusion as well as the exclusion criteria. All the patients reporting at the OPD at Rohilkhand Medical College and Hospital, Bareilly with coexisting cataract and glaucoma will be selected and divided into 2 groups randomly. Group A patients will undergo Small Incision Cataract Surgery Trabeculectomy and Group B- patients will undergo Phacoemulsification Trabeculectomy. A written and informed consent will be taken they will be evaluated thoroughly preoperatively.The patients will be reviewed at 1st day postoperative then will be assessed on 3 visits (1week, 4weeks and 12 weeks postoperative). At each visit IOP assessment, BCVA, slit-lamp examination, fundus examination. Anterior chamber, intra ocular lens and wound assessment will be done.At 12th week OCT will be done to assess the stability of peripapillary and macular GCC thickness Humphrey’s Perimetery will be done to analyse visual field changes..

The data will be entered in the Eoi InfoTM 7.1.5 Descriptive analysis will be done calculating proportions, means & standard deviation. Aprropriate statistical test will be applied depending on type & the distribution and type of data. P<0.05 will be considered significant.conclusion will be made that which amongstthe two procedure is better.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Patients with significant cataract and coexisting primary open angle glaucoma.
  • Patients with Age group more than 50years.

排除标准

  • Patients with other secondary glaucoma like Pseudoexfoliative glaucoma, Pigmentary glaucoma, neovascular glaucoma and inflammatory glaucoma.
  • Patients who underwent other surgical glaucoma treatments previously.
  • Patients with previous Ocular trauma or surgery.
  • • Patients with complicated cataract.
  • • Patients with systemic diseases such as Diabetes Mellitus and Hypertension.

结局指标

主要结局

to analyse visual field outcome and intraocular pressure preoperative and postoperative in both surgeries

时间窗: 1 weeks

次要结局

  • To analyze stability in Ganglion cell complex on Optic coherence tomography & field changes on Humphreys Perimetery preoperative & after 3 months postoperative(4 weeks)

研究者

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

DR SRISHTI JAIN

ROHILKHAND MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

Loading locations...

相似试验