EFFECT OF INTRAARTICULAR TRIAMCINOLONE HEXACETONIDE AND BETAMETHASONE ON INTRAOCULAR PRESSURE

NCT07242846 | Completed Phase 4

• 1 other identifier: 2025/55
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis (Knee OA); Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Betamethasone

ACTIVE COMPARATOR

Intraarticular betamethasone group

Drug: Diprospan

Triamcinolone Hexacetonide

ACTIVE COMPARATOR

Intraarticular triamcinolone hexacetonide

Drug: artropan

Interventions

Diprospan DRUG

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.

Betamethasone

artropan DRUG

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

Triamcinolone Hexacetonide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University

Niğde, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

betamethasone dipropionate, betamethasone sodium phosphate drug combination

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 2, 2025
• Primary Completion: November 2, 2025
• Study Completion: November 10, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

TU (1)