A prospective, randomized, comparative clinical study to compare dropless cataract surgery regime and conventional post cataract treatment regime.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- OCT - macula- central sub retinal thickness (Optovue RTVue100, USA) - 15 days
研究概览
简要总结
InstitutionalEthics committee approval will be obtained and trial registered with ClinicalTrial Registry of India.
Patientsinformed consent will be taken and the procedure explained to them in their ownlanguage.
Studydesign: Prospective, randomized, comparative, hospital-based, single centerinterventional clinical study in patients with planned phacoemulsifictionsurgery.
StudySetting: Nethradhama Superspeciality Eye Hospital, Bangalore.
Patientselection criteria:
Patientswill be enrolled into the clinical study and randomized in a ratio of 1:1 bysimple random sampling through computer generated lottery method.
Thepatients will also be willing to attend routine follow-up care as describedbelow (1 day up to 6 months post-surgery).
StudyDuration: Time frame for patient visits and examination are pre-operative, dayof surgery, postoperative days 1, 15, month 1, 3 and 6
Method ofdata collection:
Datawill be collected on the demographic profile (age, gender, address, andoccupation) and ocular parameters of the patients, as measured by slit lampexamination, 90D lens with slit lamp, and indirect ophthalmoscopy.
Before thesurgery, all patients will undergo a complete ophthalmic examination includingsubjective refraction, slit lamp biomicroscopy, noncontact tonometry (TopconCT-80), dilated fundus examination, OCT macula. (Optovue RTVue 100, USA)
Thestudy participants will be divided into two groups –
StudyGroup: Sub-Tenon’s triamcinolone acetonide (12 mg/ml) and 0.1ml intracameralmoxifloxacin (0.5%) (Auromox, Aurolab, India) administered at the end ofsurgery.
ControlGroup: Standard post-operative topical antibiotic-steroid regimen
Interventionand Procedure:
PhacoemulsificationSurgery: All patients will undergo either standard phacoemulsification cataractsurgery or Femstosecond assisted laser assisted phacoemulsification by a singlesurgeon. All procedures will be conducted under topical anesthesia.
PostoperativeIntervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 50.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary cataract surgery (age-related cataract) requiring phacoemulsification.
- •Patients with cataracts with nuclear opalescence grade 1-3, cortical cataract, posterior subcapsular cataract Preoperative best-corrected visual acuity worse than 20/
- •No history of ocular trauma, glaucoma, diabetic retinopathy, or other retinal pathology.
排除标准
- •History of previous eye surgery (except for uncomplicated cataract surgery in the other eye).
- •Active ocular infection or inflammation (KNOWN CASE OF HSV OR RETROVIRAL/HEPATITIS) .
- •Systemic conditions contraindicating steroid use (e.g., active systemic infection, poorly controlled diabetes).
- •Complicated cataracts History of uveitis, glaucoma, HIGH myopia.
结局指标
主要结局
OCT - macula- central sub retinal thickness (Optovue RTVue100, USA) - 15 days
时间窗: postoperative days 1, 15, month 1, 3 and 6
Intraocular Pressure (IOP) at postoperative day 1, 15 days, month 1, 3, and 6.
时间窗: postoperative days 1, 15, month 1, 3 and 6
AC reaction (measured via anterior chamber cell count and flare according to SUN classification) - as measured on slit lamp.
时间窗: postoperative days 1, 15, month 1, 3 and 6
Best-Corrected Visual Acuity (BCVA) at postoperative day 1, 15 days, month 1, 3, and 6.
时间窗: postoperative days 1, 15, month 1, 3 and 6
次要结局
- Rate of Postoperative Complications (e.g., endophthalmitis, posterior capsule opacification, macular edema, elevated IOP).(Patient Satisfaction (subjective questionnaire at 1 and 3 months).)