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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01801774
Other study ID # Si234/2012
Secondary ID
Status Recruiting
Phase Phase 4
First received February 26, 2013
Last updated March 31, 2015
Start date May 2012
Est. completion date July 2015

Study information

Verified date March 2015
Source Mahidol University
Contact Pitipol Choopong, MD
Phone 66868978654
Email pitipol@hotmail.com
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Complications occurred during cataract surgery such as ruptured posterior capsule, vitreous loss, or dropped nucleus

- Pregnant and lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Subtenon 20-mg triamcinolone injection
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.
Placebo


Locations

Country Name City State
Thailand Siriraj Hospital Bangkok-Noi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anterior chamber reaction proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5 postoperative day 28 No
Secondary rate of increased intraocular pressure over 21 mmHg rate of increased intraocular pressure over 21 mmHg by Goldman applanation tonometer preoperative, postoperative day 1,7,14,28,90 Yes
Secondary Changes of anterior chamber reaction over time repeated measure in changes of anterior chamber reaction over time from preoperative state to postoperative day 90 preoperative, postoperative day1, 7, 14, 28, 90 No
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