Clinical trial NCT05428683: Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery
Official title: Assistant Professor, Ophthalmology Department, Al Azhar University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacological Action
Keywords: Endophthalmitis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 84
Sex: ALL
Minimum age (years): 48
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cataract surgery followed by intravitreal injection of triamcinolone and moxifloxacin combination as a prophylaxis against endophthalmitis
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the short-term effects and safety of prophylactic intra-vitreal injection of triamcinolone-moxifloxacin combination after cataract surgery. 84 patients underwent cataract surgery associated with intra-vitreal injection of triamcinolone-moxifloxacin combination after surgery.

Detailed description: All the patients underwent the surgical removal of cataract by the same surgeon according to the standard protocols for modern phacoemulsification. Surgery was done under local anesthesia by peri-bulbar injection of local anesthetic. All operations were performed in an operating room by using an operating microscope under complete aseptic condition by using 10% povidone iodine solution applied to the skin of eye lid, eye lashes, side of the nose, eye brow and the skin of forehead. Before the operation, sterile drape and eyelid speculum were used, then 5% povidone iodine solution was applied to the bulbar conjunctiva and fornices for about 5 minutes, then was irrigated by balanced salt solution (BSS).

All the patients were followed up at the 1st day, 1st week, 1st month and at the 3rd month after the operation. At each visit the followings should be assessed: the post-operative refraction, the best corrected visual acuity and anterior and posterior segments examination for any sign of postoperative inflammation as cells and flare. Intra-ocular pressure (IOP) assessment and optical coherence tomography (OCT) images were also taken at the 1st and the 3rd postoperative months to assess the central macular thickness in suspected cases of cystoid macular edema (CME) based upon symptoms or signs observed on fundus examination, were confirmed by OCT of the macula through subjective interpretation via presence of cysts or an objective measurement of retinal thickness \> 250 microns.

Eligibility criteria: Inclusion criteria: Patients underwent uncomplicated cataract surgery with:

* A significant cataract.
* Good control of diabetes mellitus (DM) and hypertension (HPT) if present.
* Visual acuity not less than hand movement (HM).

Exclusion criteria:

The followings were the exclusion criteria:

* The use of systemic or topical steroids, topical ophthalmic antibiotics, or non-steroidal anti-inflammatory drugs (NSAIDs) for one week before operation.
* Make an additional procedure at the same time with cataract surgery.
* Those with uncontrolled glaucoma or with marked visual field defect .
* Those with a significant macular edema due to DM, HPT, retinal vein occlusion (CRVO) or due to any previous inflammatory condition.
* Those with blepharitis or any other local disease interfering with surgical intervention or affecting on the surgical outcome.
* Occurrence of intraoperative complications as posterior capsular rupture or postoperative complications as retained lens fragment.

Primary outcomes:
measure: Post operative best corrected visual acuity
timeFrame: at the end of 3rd month.
measure: A condition of the eye after cataract surgery without use of topical medications.
timeFrame: purpose of this study is to evaluate the efficacy of these used drugs after surgery not before it during follow up period at the end of 3rd month.
Secondary outcomes:
Other outcomes:
Locations:
city: Tahta
country: Egypt
facility: Emad AbdelAal Saliem
state: Sohag
Study officials:
affiliation: Assistant Prof of ophthalmology, Al Azhar university
name: Emad A Saliem
role: STUDY_DIRECTOR
References: