Knee Osteoarthritis (Knee OA)Phase 4NCT07242846
EFFECT OF INTRAARTICULAR TRIAMCINOLONE HEXACETONIDE AND BETAMETHASONE ON INTRAOCULAR PRESSURE
A Phase 4 study testing Diprospan and artropan in people with Knee Osteoarthritis (Knee OA) and Intraocular Pressure, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA), Intraocular Pressure
- What is being tested?
- Diprospan and artropan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2025to 10 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Diprospan, artropan
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiprospanDrug
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.
artropanDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone | Active comparator | Intraarticular betamethasone group Receives: Drug: Diprospan |
| Triamcinolone Hexacetonide | Active comparator | Intraarticular triamcinolone hexacetonide Receives: Drug: artropan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (before intra-articular steroid injection) and 1 week after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start2 Oct 2025
- Primary completion2 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal YAĞAR, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242846
- Sponsor's protocol ID
- 2025/55
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yagar H, Bicer KE, Yildirim Bicer G. Effect Of Intraarticular Triamcinolone Hexacetonide versus Betamethasone on Intraocular Pressure: A Prospective Randomized Study. Orthop Res Rev. 2026 Aug 7;18:620422. doi: 10.2147/ORR.S620422. eCollection 2026.
PubMed 42583198
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF INTRAARTICULAR TRIAMCINOLONE HEXACETONIDE AND BETAMETHASONE ON INTRAOCULAR PRESSURE: A PROSPECTIVE RANDOMIZED STUDY
- ClinicalTrials.gov ID
- NCT07242846
- Acronym / sponsor ID
- 2025/55
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 2 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betamethasone | Active comparator | Drug: DiprospanIntraarticular betamethasone group |
| Triamcinolone Hexacetonide | Active comparator | Drug: artropanIntraarticular triamcinolone hexacetonide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiprospanSingle 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. | Drug | Betamethasone |
| artropanSingle 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 | Drug | Triamcinolone Hexacetonide |
Primary outcome
Change in Intraocular Pressure (IOP) From Baseline to 1 Week
Time frame: Baseline (before intra-articular steroid injection) and 1 week after injection
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 42583198Yagar H, Bicer KE, Yildirim Bicer G. Effect Of Intraarticular Triamcinolone Hexacetonide versus Betamethasone on Intraocular Pressure: A Prospective Randomized Study. Orthop Res Rev. 2026 Aug 7;18:620422. doi: 10.2147/ORR.S620422. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diprospan and artropan in people with Knee Osteoarthritis (Knee OA) and Intraocular Pressure, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (IOP) From Baseline to 1 Week (time frame: Baseline (before intra-articular steroid injection) and 1 week after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07242846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.