Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03634852 |
Other study ID # |
2 Al-KindyCM |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 1, 2016 |
Est. completion date |
February 1, 2018 |
Study information
Verified date |
August 2018 |
Source |
Al-Kindy College of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Post cataract surgery bacterial endophthalmitis is a rare but the most devastating
complication with a poor visual outcome.
The preferred pattern of chemoprophylaxis varied world widely. The use of preoperative
povidone iodine is universal. Most European surgeons prefer the use of Intracameral (IC)
antibiotics whereas topical fluoroquinolone that prescribed perioperatively is the most
common pattern in the United state(US). The current study aimed to evaluate the effectivity
and safety of a combination of diluted IC Moxifloxacin and subconjunctival (SC) Triamcinolone
acetonide as prophylaxis of bacterial endophthalmitis and postoperative inflammation in five
hundred phacoemulsification surgeries and compare its results with the same number of
patients treated by topical Moxifloxacin hydrochloride and Dexamethasone eye drops when given
four times a day for 1month postoperatively.
Description:
Study design and populations:
The current clinical trial included a total 1000 patients with visually significant cataract
scheduled to have phacoemulsification surgery at an Eye specialty private hospital in Baghdad
/Iraq during 18 months period from 1st of October 2016 to 1st of February 2018 by two
surgeons.
The current two methods of prophylaxis of postoperative endophthalmitis and inflammation were
discussed with the patients and informed consent was obtained about the treatment and the
enrollment in the current study.
Two methods of prophylaxis of postoperative bacterial endophthalmitis and inflammation were
planned to use. For 500 patients (group 1) topical moxifloxacin hydrochloride 0.5%
(Vigamox,Alcon) and dexamethasone 0.1%(Maxidex, Alcon) eye drops prescribed four times a day
for 1-month postoperatively ,while for the remaining 500 patients (group 2), intracameral
(IC) diluted moxifloxacin 0.1% and subconjunctival triamcinolone acetonide 4 mg/0.4 cc is the
combination that planned to used for prophylaxis.
Preoperative evaluations:
The two surgeons follow the same protocol for the preoperative evaluation including slit
lamp, Goldmann applanation tonometry(AT900, Haag-Streit Diagnostics, Switzerland), dilated
fundus examination and macular optical coherence tomography (OCT)(Optovue, RTVue-100,
Fremont, CA).
Follow- up visits were on the first postoperative day, 1week, 1 month, and 3months
postoperatively.
The mean age of patients in group 1 was 59.4 years ± 9.04, 300 were female and 200 were male,
160 with type 2 diabetes mellitus without retinopathy and the preoperative intraocular
pressure (IOP) range were from 10 to 25 mmHg with mean 14.49 mmHg ± 3.11.
Group 2 patients had a mean age of 59.7 ±8.84, 320 were female and 180 were male, 140 with
good controlled diabetes and preoperative IOP mean was 14.47 mmHg ±3.10 range was from
9.5-20.6 mmHg.
statistical analysis: Minitab 16 software used for data statistical analysis, data were
expressed in mean ± standard deviation (SD), for each group the preoperative baseline versus
the corresponding postoperative data were compared by paired-sample t-test, while for the
comparison of the 2 independent groups we used two-sample t-test and the results considered
statistically significant if P value < 0.05.