InflammationPhase 4NCT01801774
Efficacy Comparison Study of Steroids to Control Post-operative Inflammation
A Phase 4 study testing Subtenon 20-mg triamcinolone injection in people with Inflammation and Intraocular Pressure, run by Mahidol University at 1 site in Thailand.
Trial summary
Phacoemulsification is a quick method with less complication for cataract surgery. Due to the use of ultrasonic energy, it produced more post-operative inflammation than other methods. Many routes of steroid had been used to control post-operative inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Intraocular Pressure
- What is being tested?
- Subtenon 20-mg triamcinolone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- May 2012to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years old
- Uncomplicated cataract patient scheduled for phacoemulsification and posterior chamber intraocular lens implantation
- No History of prior intraocular procedures or any eye diseases such as uveitis, glaucoma, diabetic retinopathy
- No History of systemic autoimmune diseases
- No History of allergy to corticosteroids or to any component of the study medications
- No History of using corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunomodulating agents within 3 months prior to surgery
Who cannot join
- Complications occurred during cataract surgery such as ruptured posterior capsule, vitreous loss, or dropped nucleus
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Pitipol Choopong, MD, 66868978654, pitipol@hotmail.com
Pitipol Choopong, MD
About this study
Official title: Quantitative Comparison of the Efficacy of Subtenon 20-mg Triamcinolone Injection With 0.1% Dexamethasone Eye Drop in Controlling Intraocular Inflammation After Phacoemulsification
Phacoemulsification is a quick method with less complication for cataract surgery. Due to the use of ultrasonic energy, it produced more post-operative inflammation than other methods. Many routes of steroid had been used to control post-operative inflammation. The investigators here compare the efficacy of single depot steroid subtenon injection (20-mg triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling inflammation after uneventful phacoemulsification.
Read the detailed description
Cataract is one of the most common causes of blindness in the world. Surgical removal of lens is the only treatment for cataract, which now shifts from extracapsular cataract extraction to phacoemulsification. Although phacoemulsification provides faster operating time and gives better optical result and rapid recovery to the patient, it causes more inflammation post-operatively compare with extracapsular cataract extraction. Corticosteroids eye drops are mainly use to control intraocular inflammation after the surgery.
Other routes of corticosteroids have been introduced to increase the intraocular level and to increase the patient's compliance. Subtenon triamcinolone injection is easy and safe. Antiinflammatory effect of single subtenon triamcinolone injection lasts about 4-6 weeks. This method has been used in combination with corticosteroid eye drop to control the inflammation after cataract surgery in uveitic patients. It shows potency in controlling of intraocular inflammation with lower rate of increasing the intraocular pressure. The investigators here quantitatively compare the efficacy of subtenon 20-mg triamcinolone injection with 0.1% dexamethasone eye drop in controlling intraocular inflammation after uneventful phacoemulsification.
- Conditions
- Inflammation, Intraocular Pressure
- Being tested
- Subtenon 20-mg triamcinolone injection, Placebo
- Keywords
- post-operative inflammation, steroid, intraocular pressure
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtenon 20-mg triamcinolone injectionDrug
Also called Triamcinolone
Treatment arm will receive single subtenon 20-mg triamcinolone with gentamicin injection after uneventful phacoemulsification. 0.3% Tobramycin eye drop will be given to treatment arm for 28 days to blind the patient.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Placebo comparator | Dexamethasone 0.1%/Tobramycin 0.3% eye drop 4 times per day for 28 days Receives: Drug: Placebo |
| Triamcinolone | Active comparator | Subtenon 20-mg Triamcinolone injection Receives: Drug: Subtenon 20-mg triamcinolone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber reaction
proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5
Measured: postoperative day 28
Secondary outcomes (2)
rate of increased intraocular pressure over 21 mmHg
rate of increased intraocular pressure over 21 mmHg by Goldman applanation tonometer
Measured: preoperative, postoperative day 1,7,14,28,90
Changes of anterior chamber reaction over time
repeated measure in changes of anterior chamber reaction over time from preoperative state to postoperative day 90
Measured: preoperative, postoperative day1, 7, 14, 28, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pitipol Choopong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801774
- Sponsor's protocol ID
- Si234/2012
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Comparison of the Efficacy of Subtenon 20-mg Triamcinolone Injection With 0.1% Dexamethasone Eye Drop in Controlling Intraocular Inflammation After Phacoemulsification
- ClinicalTrials.gov ID
- NCT01801774
- Acronym / sponsor ID
- Si234/2012
- Conditions
- Inflammation, Intraocular Pressure
- Keywords
- post-operative inflammation, steroid, intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 1 Mar 2013 (estimated)
- 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.
Phacoemulsification is a quick method with less complication for cataract surgery. Due to the use of ultrasonic energy, it produced more post-operative inflammation than other methods. Many routes of steroid had been used to control post-operative inflammation. The investigators here compare the efficacy of single depot steroid subtenon injection (20-mg triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling inflammation after uneventful phacoemulsification.
Detailed description
Cataract is one of the most common causes of blindness in the world. Surgical removal of lens is the only treatment for cataract, which now shifts from extracapsular cataract extraction to phacoemulsification. Although phacoemulsification provides faster operating time and gives better optical result and rapid recovery to the patient, it causes more inflammation post-operatively compare with extracapsular cataract extraction. Corticosteroids eye drops are mainly use to control intraocular inflammation after the surgery.
Other routes of corticosteroids have been introduced to increase the intraocular level and to increase the patient's compliance. Subtenon triamcinolone injection is easy and safe. Antiinflammatory effect of single subtenon triamcinolone injection lasts about 4-6 weeks. This method has been used in combination with corticosteroid eye drop to control the inflammation after cataract surgery in uveitic patients. It shows potency in controlling of intraocular inflammation with lower rate of increasing the intraocular pressure. The investigators here quantitatively compare the efficacy of subtenon 20-mg triamcinolone injection with 0.1% dexamethasone eye drop in controlling intraocular inflammation after uneventful phacoemulsification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Placebo comparator | Drug: PlaceboDexamethasone 0.1%/Tobramycin 0.3% eye drop 4 times per day for 28 days |
| Triamcinolone | Active comparator | Drug: Subtenon 20-mg triamcinolone injectionSubtenon 20-mg Triamcinolone injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age older than 18 years old
- Uncomplicated cataract patient scheduled for phacoemulsification and posterior chamber intraocular lens implantation
- No History of prior intraocular procedures or any eye diseases such as uveitis, glaucoma, diabetic retinopathy
- No History of systemic autoimmune diseases
- No History of allergy to corticosteroids or to any component of the study medications
Key exclusion criteria (2 listed)
- Complications occurred during cataract surgery such as ruptured posterior capsule, vitreous loss, or dropped nucleus
- Pregnant and lactating women
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 |
|---|---|---|
| Subtenon 20-mg triamcinolone injectionAlso: TriamcinoloneTreatment arm will receive single subtenon 20-mg triamcinolone with gentamicin injection after uneventful phacoemulsification. 0.3% Tobramycin eye drop will be given to treatment arm for 28 days to blind the patient. | Drug | Triamcinolone |
| Placebo | Drug | Dexamethasone |
Primary outcome
Anterior chamber reaction
Time frame: postoperative day 28
proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5
2 secondary outcomes
rate of increased intraocular pressure over 21 mmHg
Time frame: preoperative, postoperative day 1,7,14,28,90
Changes of anterior chamber reaction over time
Time frame: preoperative, postoperative day1, 7, 14, 28, 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Pitipol Choopong, MD principal investigator
Mahidol University
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 Subtenon 20-mg triamcinolone injection in people with Inflammation and Intraocular Pressure, run by Mahidol University at 1 site in Thailand.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 2015. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pitipol Choopong, MD (66868978654, pitipol@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior chamber reaction (time frame: postoperative day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2015.