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Completed

NCT Number: NCT07567118

A Study Comparing Sub-Tenon Steroid Injection Versus Eye Drops for Reducing Postoperative Inflammation After Cataract Surgery

After cataract surgery, postoperative inflammation is commonly treated with corticosteroid eye drops such as prednisolone acetate 1%. However, frequent dosing may reduce patient compliance. This study compares topical corticosteroid drops with a single sub-Tenon's injection of triamcinolone acetonide in controlling postoperative inflammation after uncomplicated cataract surgery.

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Key information

Age range

52 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus, Faculty of Medicine

Damascus, Syria

About this study

Background: Postoperative ocular inflammation is a common physiological response following cataract surgery; however, excessive inflammation may compromise visual outcomes. Topical corticosteroids, particularly prednisolone acetate 1%, remain the standard treatment, but their use is limited by poor patient compliance and the need for frequent dosing. Sub-Tenon's corticosteroid injection offers a potential alternative with a prolonged anti-inflammatory effect.

Objective: To compare the safety and efficacy of a single sub-Tenon's injection of triamcinolone acetonide versus topical prednisolone acetate 1% in controlling postoperative inflammation after uncomplicated cataract surgery.

Methods: This prospective, randomized, interventional comparative study included 72 patients undergoing phacoemulsification surgery. Participants were randomly assigned into two groups: Group 1 received topical prednisolone acetate 1% according to a tapering regimen, while Group 2 received a single sub-Tenon's injection of triamcinolone acetonide (40 mg/mL).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients eligible for senile cataract surgery meeting the following conditions:

Best-corrected visual acuity less than or equal to 0.5. Nuclear sclerosis grades NC1, NC2, NC3, or NC4 according to LOCS III, regardless of the grade of cortical or posterior subcapsular cataract.

Age 50 years and older.

Exclusion criteria

Patients with non-age-related cataracts (congenital, infantile, or drug-induced).

Patients with a history of previous intraocular surgery. Patients with any form of glaucoma. Patients with pseudoexfoliation syndrome. Patients with diabetes mellitus. Patients with uveitis. Patients scheduled for concurrent intraocular surgery at the time of cataract extraction (e.g., trabeculectomy or vitrectomy).

Patients using long-term topical ocular medications. Patients with only one functional eye. Patients with poor pupil dilation, defined as a pupil diameter of 5.5 mm or less, those requiring iris dilators, or those who experienced iris trauma during surgery.

Effective phacoemulsification time (EPT) exceeding 2 minutes. Patients who were non-compliant with follow-up visits. Patients who developed postoperative complications unrelated to the study treatment (such as endophthalmitis or intraocular lens dislocation).

Treatment and study plan

Triamcinolone acetonide injection

Drug

Patients in this group received an intraoperative subtenon injection of triamcinolone acetonide at the end of phacoemulsification surgery. The injection was administered to reduce postoperative inflammation.

Prednisolone acetate 1%

Drug

Patients in this group received topical prednisolone acetate 1% eye drops postoperatively according to the standard regimen to control inflammation after phacoemulsification surgery.

Primary outcomes

  1. Degree of postoperative ocular inflammation assessed by slit-lamp examination (cells and flare grading) after phacoemulsification surgery.

    Time frame: 1day, 1week, 2week, 1month

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Study Of The Safety And Efficacy Of Intraoperative Subtenon Triamcinolone Acetonide Injection Versus Topical Prednisolone Acetate 1% In Reducing Postoprerative Inflammation After Phacoemulsification

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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