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临床试验/CTRI/2024/05/068093
CTRI/2024/05/068093尚未招募3 期

To Compare Central Macular Thickness in Patients Undergoing Phacoemulsification with or without Intravitreal Dexamethasone Injection in Patients with Coexisting Diabetic Macular Edema

Northern Railway Central Hopital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare change in central macular thickness by OCT

研究概览

简要总结

Phacoemulsification will be performed on each patient, and IOL placement was aided. Every surgery will be performed under 4% lignocaine topical anesthesia. The patient receives eye drops (ophthalmic solution containing gatifloxacin and prednisolone) prior to surgery. The patient will be given eye drops (tropic amide 0.8% and phenylephrine 5% w/v) to dilate their pupils on the day of surgery. The conjunctival sac is injected with one drop of a 5% povidone- iodine solution to eradicate the local saprophytic microbiological flora. After cleaning, the patient’s eye will be covered. A clear corneal incision (1 mm anterior to the limbus) will be made, and one entryon a steep axis using a 2.8 mm keratome was made using a 15 degree lance tip (side port blade) into the anterior chamber (AC). In order to stain the anterior capsule, AC was injected with 0.06% trypan blue dye. The dye will be washed out with BSS (Balanced Salt Solution). Viscoelastic 1% sodium hyaluronate will injected to form AC, followed by anterior continuous curvilinear capsulorhexis with a capsulotomy needle.

After that, the anterior chamber will decompress, and hydro delineation and hydro dissection will be completed. A 2% hydroxypropyl methylcellulose viscoelastic substance is applied to the corneal endothelium, and the (STELLARIS, B & L) phacoemulsification system will be used to phacoemulsify the nucleus. Next, a co-axial/bimanual irrigation-aspiration probe will be used to aspirate the cortical matter. After adding sodium hyaluronate viscoelastic to the capsular bag, a single-piece foldable hydrophilic four haptic IOL (Bausch n Lomb) will be placed inside of it. Using an irrigation aspiration probe, the viscoelastic was removed, and the surgery was concluded by hydrating the entry wounds with BSS. The eye is closed using 0.5 moxifloxacin eye drops once the integrity of the wound has been confirmed. Post the phacoemulsification of the concerned eye, the concerned eye will be cleaned and draped. Lignocaine 4% will be instilled topically. A distance of 3.5mm shall be marked from limbus inthe infratemporal quadrant. A 0.05 ml dose of intravitreal Dexamethasone will be injected into vitreous cavity by 30 gauge needle under microscopic visualization.Then central macular thickness by OCT, intra ocular pressure by NCT and intra opeartive complications would be compared.

All the above parameters would be noted at baseline day7, day30, day60, day90 following the injection into the vitreous cavity by a regular faculty in ophthalmology.

If      during the      follow up      any      complication occurs-Iritis     (inflammation of iris), Vitritis (inflammation of vitreous), Retinal vasculitis (inflammation of retinal veins and arteries) then the patient will be managed accordingly with anti-inflammatory agents.

If any of the patient develops Retinal venous occlusion, vitreous hemorrhage, endophthalmitis, Retinal detachment or lens injury then patient will be excluded from the study and will be managed by expert consultant accordingly.

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 and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1.Type 1 and 2 Diabetes Mellitus.
  • 2.Visual Acuity of 6/12 or less.
  • 3.Central macular thickness of 300 microns or less.
  • 4.Any gender.

排除标准

  • 1 Any co-existing retinal pathology apart from diabetic retinopathy likely to affect visual acuity.
  • 2 Vitrectomised Eye.
  • 3 Uncontrolled Diabetes defined of HbA1c more than 10 percent.
  • 4 Any intra operative or post-operative complication effecting the visual acuity.

结局指标

主要结局

To compare change in central macular thickness by OCT

时间窗: 1 week 1 month 2 months and 3 months

次要结局

  • To compare change in intraocular pressure by NCT following the procedure(at 1 week, 1 month, 2 months and 3 months follow up.)

研究者

发起方
Northern Railway Central Hopital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Arnav Singhal

Northern Railway Central Hospital

研究点 (1)

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