EFFECT OF INTRAARTICULAR TRIAMCINOLONE HEXACETONIDE AND BETAMETHASONE ON INTRAOCULAR PRESSURE

EFFECT OF INTRAARTICULAR TRIAMCINOLONE HEXACETONIDE AND BETAMETHASONE ON INTRAOCULAR PRESSURE: A PROSPECTIVE RANDOMIZED STUDY

This study is being done to find out whether two commonly used corticosteroid injections for knee osteoarthritis - betamethasone and triamcinolone hexacetonide - have different effects on eye pressure (intraocular pressure). Adults with painful early-stage knee osteoarthritis who have not improved with standard treatments receive one of these injections into the knee joint as part of their usual care. Eye pressure in both eyes is measured before the injection and one week later. By comparing the change in eye pressure between the two steroid groups, the study aims to better understand the risk of steroid-related increases in eye pressure and to help doctors choose safer treatment options, especially for patients who may be at risk for glaucom

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Knee Osteoarthritis (Knee OA)
• Intervention / Treatment: Drug: Diprospan; Drug: artropan

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Niğde, Turkey (Türkiye)
    • Nigde Omer Halisdemir University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Symptomatic early-stage knee osteoarthritis Patients aged 18-75 years No prior eye surgery No history of elevated IOP or glaucoma diagnosis Patients not receiving any medical treatment altering IOP

Exclusion Criteria:

• IOP >21 mm Hg Patients with a previous or current diagnosis of glaucoma Patients aged <18 and >75 years History of or ongoing ocular disease Use of medications (oral CSs, diazoxide, etc.) altering IOP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Betamethasone; Intraarticular betamethasone group	Drug: Diprospan; Single intra-articular injection of betamethasone into the affected knee joint at baseline as part of routine care for symptomatic early-stage knee osteoarthritis. No additional intra-articular corticosteroid injections are given during the follow-up period.
Active Comparator: Triamcinolone Hexacetonide; Intraarticular triamcinolone hexacetonide	Drug: artropan; Single intra-articular injection of triamcinolone hexacetonide into the affected knee joint at baseline as part of routine care for symptomatic early-stage knee osteoarthritis. No additional intra-articular corticosteroid injections are given during the follow-up period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intraocular Pressure (IOP) From Baseline to 1 Week	ntraocular pressure (IOP) in both eyes will be measured in mmHg using noncontact tonometry at baseline (before the intra-articular injection) and 1 week after the injection. Change in IOP (ΔIOP) will be calculated for each eye as the value at 1 week minus the baseline value. The primary outcome is the mean change in IOP in each treatment group	Baseline (before intra-articular steroid injection) and 1 week after injection

Collaborators and Investigators

• Sponsor: Nigde Omer Halisdemir University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Actual): November 2, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; betamethasone dipropionate, betamethasone sodium phosphate drug combination
• Other Study ID Numbers: 2025/55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No