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Trials / Completed

CompletedNCT05428683

Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery

Assistant Professor, Ophthalmology Department, Al Azhar University

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Emad Abdel Aal Saliem · Academic / Other
Sex
All
Age
48 Years – 66 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGintra-vitreal triamcinolone-moxifloxacin injection after cataract surgery as a prophylactic measures against post-operative endophthalmitisAt the end of surgery, 4mg triamcinolone acetonide and 0.2mg moxifloxacin from 0.5 moxifloxacin preservative-free eye drop) were injected once inferotemporally 3.5 mm posterior to the limbus via pars plana into the vitreous cavity by using 30 G needle.

Timeline

Start date
2020-12-03
Primary completion
2021-08-17
Completion
2021-12-10
First posted
2022-06-23
Last updated
2022-06-27

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05428683. Inclusion in this directory is not an endorsement.