EFFECT OF INTRAARTICULAR TRIAMCINOLONE HEXACETONIDE AND BETAMETHASONE ON INTRAOCULAR PRESSURE

NCT ID: NCT07242846

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-02
• Study Completion Date: 2025-11-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Betamethasone

Intraarticular betamethasone group

Group Type: ACTIVE_COMPARATOR

Diprospan

Intervention Type: 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.

Triamcinolone Hexacetonide

Intraarticular triamcinolone hexacetonide

Group Type: ACTIVE_COMPARATOR

artropan

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Hilal YAĞAR

Assist. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Niğde Ömer Halisdemir University

Niğde, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025/55

Identifier Type: -

Identifier Source: org_study_id