Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery

Pharmacological Action Clinical Trial

Official title:

Assistant Professor, Ophthalmology Department, Al Azhar University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428683
• Other study ID #: 1221975
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: December 10, 2021

Study information

• Verified date: June 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 10, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacological Action

Intervention

Drug:
• intra-vitreal triamcinolone-moxifloxacin injection after cataract surgery as a prophylactic measures against post-operative endophthalmitis
At 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.

Locations

Country	Name	City	State
Egypt	Emad AbdelAal Saliem	Tahta	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Emad Abdel Aal Saliem

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative best corrected visual acuity	describe the differences between pre & post operative best corrected visual acuity by snellen's chart. The mean BCVA showed a statistically significant differences between the preoperative and the postoperative values, where the main BCVA improved from 1.21±0.27 logMAR before operation (at baseline) to 0.19±0.14 logMAR at the 3rd month. For statistical analysis, the best- corrected visual acuity data were transformed to LogMAR. Investigators calculated the mean, standard deviation, range, confidence interval, and Pearson correlation.	at the end of 3rd month.
Primary	A condition of the eye after cataract surgery without use of topical medications.	By SLITLAMP examination, investigators search for signs of postoperative endophthalmitis or inflammations as cells or flare that required supplemental anti-inflammatory medications. So, evaluate the use of triamcinolone-moxifloxacin combination after cataract surgery when injected intra-vitreally against postoperative endophthalmitis and/or other intraocular inflammations without use of topical anti-infective and/or anti-inflammatory medications whether before or even after cataract surgery.	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.