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

NCT07567118 | Completed

• 1 other identifier: Damascus-Ophth.
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Inflamation; Phacoemulsification

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1day, 1week, 2week, 1month

Study Arms (2)

Intraoperative Subtenon Triamcinolone Acetonide

EXPERIMENTAL

Drug: Triamcinolone acetonide injection

Topical Prednisolone Acetate 1%

ACTIVE COMPARATOR

Drug: prednisolone acetate 1%

Interventions

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.

Topical Prednisolone Acetate 1%

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.

Intraoperative Subtenon Triamcinolone Acetonide

Eligibility Criteria

• Age: 52 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus, Faculty of Medicine

Damascus, Syria

Location

MeSH Terms

Conditions

Cataract

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• sameh Kh issa, professor

  University of Damascus, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2023
• Primary Completion: January 6, 2025
• Study Completion: February 2, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)