Impact Of 0.1% nepafenac on macular and choroidal thickness after uncomplicated Phacoemulsification surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Choroidal thickness measurements at 5 points (sub-foveal, 500µm temporal, nasal, superior & inferior to fovea) measured using EDI-OCT
研究概览
简要总结
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The study is planned the department of Ophthalmology at our Tertiary care Hospital and due permission from the Institutional Ethics Committee and Review Board is taken.
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55-65 year old Type 2 Diabetic patients presenting to Ophthalmology OPD requiring cataract surgery and with previous history of diabetic retinopathy will be enrolled in the study.
- A detailed history will be obtained from all patients including duration of diabetes, diabetic control and medications of diabetes mellitus. History pertaining to previous ocular trauma, ocular intervention like surgery, intravitreal injection or laser will also be obtained.
- All the patients will undergo ophthalmic examination including visual acuity assessment by Snellen’s chart, refraction & best corrected visual acuity, Anterior segment examination by Slit lamp bio-microscopy and IOP by NCT. After dilatation, a detailed central fundus evaluation with slit lamp bio-microscopy with a 90 D lens followed by peripheral fundus examination with
an indirect ophthalmoscope & 20D lens
- Accordingly as per pre set inclusion-exclusion criteria study sample is filtered.
- Simple random sampling is done by lottery method to make 2 groups. Both the groups will undergo EDI-OCT for baseline preoperative choroidal thickness and then phacoemulsification with posterior chamber intraocular lens implantation.
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Group 1, the intervention group will receive 0.1% nepafenac drops 3times/day along with antibiotic-steroid combination eye drops in tapering doses from pre op day to post of 1 month. On the other hand group 2 i.e control group will receive antibiotic-steroid combination eye drops and artificial tear substitute as placebo for same time period as group 1.
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EDI-OCT done on 1 week & 1 month postop.
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All the EDI-OCT charts will be measured by the calipers on the inbuilt software of Zeiss SD OCT. Choroidal thickness measurements at 5 points (sub-foveal, 500µm temporal, nasal, superior & inferior to fovea)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic patients with no clinical evidence of diabetic retinopathy who have senile immature cataract (gr 2, gr 3) scheduled to undergo cataract extraction and posterior chamber Intra-ocular lens implantation.
排除标准
- •Anterior segment pathology (corneal opacities, PEX, dense cataract)
- •Posterior segment pathology (DR, ARMD, retinal vascular diseases, uveitis)
- •Intra & Postoperative complications(TASS, raised IOP) 4.History of chronic oral/topical medication, intraocular surgery, ocular trauma.
结局指标
主要结局
Choroidal thickness measurements at 5 points (sub-foveal, 500µm temporal, nasal, superior & inferior to fovea) measured using EDI-OCT
时间窗: Choroidal thickness measurements at 5 points using EDI-OCT on preoperative day, post operative 1 week and post op 1 month
次要结局
- Compare subfoveal choroidal thickness at 3 months post op with initial pre op reading(3 months)
研究者
Dr Anushree C M
Command hospital (Central Command), Lucknow