Clinical trial NCT03634852: A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery
Official title: A Two Different Chemoprophylaxis Approaches After Phacoemulsification Surgery in One Thousand Patients in Iraq :a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endophthalmitis Postoperative
Keywords: IC Moxifloxacin hydrochloride
SC triamcinolone acetonide
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
Collaborators: name: Al-Kindy College of Medicine
First posted: 2018-08-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 38
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria: for both groups; the patients with visually significant cataract were included in the current study should have

1. no current or previous intraocular inflammation,
2. no history of glaucoma or topical corticosteroid responsiveness.
3. All the included patients had normal preoperative fundus examination and normal preoperative macular OCT.
4. All the patients who have the above-mentioned inclusion criteria were included in the current comparison whether phacoemulsification surgery was complicated or not.

Exclusion Criteria:

1. For group 2; any patient used a topical antibiotic, nonsteroidal anti-inflammatory drug (NSAID) or corticosteroid up to 1 week before the planned day of surgery,
2. any patient with a history of glaucoma or steroid responsiveness
3. any patient with significant maculopathy were excluded from the current comparison.

Primary outcomes:
measure: Incidence of Bacterial endophthalmitis in 1000 phacoemulsification surgeries
timeFrame: The duration of follow up for each patient was a 3 months postoperatively.
Secondary outcomes:
measure: Intraocular pressure(IOP) was measured on 1week,1month,and 3 months visits by Goldmann applanation tonometry .
timeFrame: The duration of follow up for each patient was a 3 months postoperatively.
Other outcomes:
measure: Break through inflammation (A significant anterior chamber reaction that may notice after 10 days postoperatively).
timeFrame: The duration of follow up for each patient was a 3 months postoperatively.
measure: Central macular thickness (CMT)
timeFrame: OCT was done preoperatively and 3 months postoperatively.
Locations:
Study officials:
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