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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07567118
Enrollment
72
Registered
2026-05-05
Start date
2023-05-01
Completion date
2025-02-02
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Inflamation, Phacoemulsification

Keywords

Cataract surgery, sub-Tenon's injection, triamcinolone acetonide

Brief summary

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.

Detailed description

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).

Interventions

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.

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
52 Years to 76 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Degree of postoperative ocular inflammation assessed by slit-lamp examination (cells and flare grading) after phacoemulsification surgery.1day, 1week, 2week, 1month

Countries

Syria

Contacts

PRINCIPAL_INVESTIGATORsameh Kh issa, professor

University of Damascus, Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026