Clinical Trial: Comparing Phaco/IOL Versus Phaco/IOL + Goniosynechialysis in Subjects With PACG
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Clinical Trial Comparing Phacoemulsification and Goniosynechialysis With Phacoemulsification Alone in the Management of Primary Angle Closure
Brief Summary: The purpose of this study is to determine if phacoemulsification with intraocular lens implant (phaco/IOL) alone or combined with goniosynechialysis is better at controlling intraocular pressure in subjects with primary angle closure.
Detailed Summary:
Study Background
Glaucoma is the worlds' leading cause of irreversible blindness with nearly 7 million bilaterally blind due to the disease, by some estimates, and as such, represents a disease with significant associated morbidity. Furthermore, as glaucoma is primarily a disease of old age, as the number of elderly people in the world continues to rise, the number of people with glaucoma blindness is likely to have increasing economic burden and public health costs.
Primary glaucoma is classified into 2 types, Primary Open Angle Glaucoma (POAG) and Primary Angle Closure Glaucoma (PACG). Classification depends on configuration of the anterior chamber drainage angle, specifically if it is open or if it shows evidence of closure. The proportions of people with POAG and PACG are approximately equal, with the latter disease more common in Asians and women. Although the result of both diseases is progressive cupping of the optic disc with corresponding visual fields loss, the mechanism by which this occurs is thought to be quite different in the two diseases. In POAG the mechanism is still to be established but in PACG it is thought that apposition of the peripheral iris to the drainage angle results in damage to the trabecular meshwork (TM) and the formation of peripheral anterior synaechiae (PAS) which act as a mechanical obstruction of aqueous outflow via the trabecular meshwork. This in turn results in raised intraocular pressure (IOP) and subsequent optic nerve damage. Apposition can occur in anatomically predisposed eyes, although a physiological dynamic element is likely to be involved also. Areas of the TM not obstructed by PAS are likely to retain some function, although it is not clear if this is at the same level as in normal subjects. The functioning of the TM posterior to the areas of PAS has also yet to be establi
Sponsor: Singapore National Eye Centre
Current Primary Outcome: Intraocular pressure as measured by Goldmann applanation tonometry [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Per-operative and post-operative complications as determined by the examining/operating clinician [ Time Frame: 1 year ]
- Peripheral anterior synechiae development as measured by gonioscopy [ Time Frame: 1 year ]
- Degree of angle opening as measured by gonioscopy and anterior segment ocular coherence tomography [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Singapore National Eye Centre
Dates:
Date Received: February 12, 2015
Date Started: June 2011
Date Completion:
Last Updated: February 25, 2015
Last Verified: February 2015
