Intraocular Pressure (IOP) Lowering Effect of Selective Laser Trabeculoplasty Versus Prostaglandin Analogues in Angle Closure Glaucoma
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|ClinicalTrials.gov Identifier: NCT01004900|
Recruitment Status : Unknown
Verified May 2010 by Singapore Eye Research Institute.
Recruitment status was: Recruiting
First Posted : October 30, 2009
Last Update Posted : May 12, 2010
Glaucoma affects 66 million people worldwide and is the leading cause of irreversible blindness, and Primary angle-closure glaucoma (PACG) is a major form of glaucoma in Asia.
Laser peripheral iridotomy (LPI) has been advocated as the first line treatment in all cases of PACG. In addition to relieving the relative pupil block element of the condition, it can open up the drainage angle, alleviating appositional and synechial angle-closure and in the long-term this may control intraocular pressure (IOP) and prevent progression of glaucomatous optic neuropathy. However recent data indicate that iridotomy is not successful in controlling IOP in the long term, and the majority of cases develop a clinically significant rise in IOP requiring medical therapy or surgery.
Laser trabeculoplasty has been a recognized treatment option for Primary open angle glaucoma (POAG) since the 1980s. Recently a more selective and less destructive method of performing laser trabeculoplasty has evolved. Selective Laser Trabeculoplasty (SLT) specifically targets the pigmented trabecular meshwork cells without producing collateral damage and destruction to adjacent structures. Morphologic study performed on human autopsy eyes treated with SLT noted no structural or collateral thermal damage to the trabecular beams in the uveal and corneoscleral meshwork. As SLT specifically has its effect on the targeted pigmented trabecular meshwork it is unlikely to generate PAS. It may be a useful treatment option for PACG patients in whom the angle has widened following laser peripheral iridotomy.
The proposed study is a randomized controlled trial to assess the effectiveness of SLT in reducing IOP in cases of PACG in which the angle has opened up following LPI, but IOP remains high(>21 mmHg). 100 subjects will be randomized to receive either SLT or medical treatment to achieve IOP control. They will be followed up for 6 months.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Procedure: Selective Laser Trabeculoplasty Drug: Travoprost/ Timolol/ Azopt/ Brimonidine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Selective Laser Trabeculoplasty With Prostaglandin Analogues for Lowering Intraocular Pressure in Eyes With Primary Angle Closure Glaucoma|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||March 2011|
|Active Comparator: Trabeculoplasty||
Procedure: Selective Laser Trabeculoplasty
This is a laser procedure used to treat glaucoma by reducing the pressure in the eye. SLT works by using laser light to stimulate the body's own healing response to lower your eye pressure. Using a special wavelength and energy, the laser affects only pigmented (melanin containing) cells of your eye. SLT improves the flow of fluid in the eye, which in turn lowers your eye pressure.
|Active Comparator: Control (Medication)||
Drug: Travoprost/ Timolol/ Azopt/ Brimonidine
Travoprost (Topical eye drops) administered once daily before sleep
- Intraocular Pressure [ Time Frame: 6 months ]Fluid pressure inside the eye
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004900
|Contact: Tin Aung, FRCOphthemail@example.com|
|Singapore National Eye Centre||Recruiting|
|Singapore, Singapore, 168751|
|Contact: Tin Aung, FRCOphth 62277255 firstname.lastname@example.org|
|Principal Investigator: Tin Aung, FRCOphth|
|Principal Investigator:||Tin Aung, FRCOphth||Singapore National Eye Centre|