A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery
Condition: Endophthalmitis Postoperative
MeSH terms: Endophthalmitis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Moxifloxacin hydrochloride 0.5% eye drops; Dexamethasone 0.1% eye drops; Intracameral Moxifloxacin 0.1%; Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): were prescribed four times a day for 1-month postoperatively; were prescribed four times a day for 1-month postoperatively; Auromox (0.5%): is a sterile clear yellow pale colored preservative free isotonic ophthalmic solution with pH 6.0 to 7.5 and osmolarity 620 -320 milliosmol ( mOsm).The sterile Auromox vial contains 1cc Moxifloxacin hydrochloride 5.45 mg equivalent to 5mg of Moxifloxacin. This product is manufactured by Aurolab an Indian pharmaceutical company. Auromox is available in many countries including Iraq.
Each vial enough for 15 different patients by using a sterile needle and 5cc syringe. By the sterile hand's, the surgeon draws the whole 1cc of Moxifloxacin 0.5% and diluted with 4 cc of balanced salt solution (BSS) to get 5 mg in 5 cc (0.1%) then draw 0.2 cc for each patient.; Aurocort is a preservative-free Triamcinolone acetonide (40 mg /1cc), with along acting depot preparation of triamcinolone in 1cc vial also the product of Aurolab company and commercially available in our country.
The whole 1cc had been drawn and diluted with 3cc of BSS and SC injection of 4 mg in 0.4 cc of Triamcinolone was given (as a final step in the surgery) 6mm from the limbus usually an inferotemporal site that is easily accessible and the plaque that formed will be not visible within palpebral fissure
Other intervention name(s): Vigamox eye drops; Maxidex eye drops; Auromox; Aurocort
Intervention MeSH terms: Moxifloxacin; Dexamethasone; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Ophthalmic Solutions; Norgestimate, ethinyl estradiol drug combination; Triamcinolone diacetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IC Moxifloxacin hydrochloride; SC triamcinolone acetonide