To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.
Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
316
The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.
The patients enrolled underwent trabeculectomy surgery
Eye & ENT Hospital
Shanghai, China
RECRUITINGIntraocular pressure (IOP) change at one month
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.
Time frame: one month
IOP change at three months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.
Time frame: three months
IOP change at six months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.
Time frame: six months
IOP change at one year
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.
Time frame: one year
IOP change at two years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.
Time frame: two years
IOP change at three years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.
Time frame: three years
Best corrected visual acuity at one month
Best corrected visual acuity of participants after surgery at one month
Time frame: one month
Best corrected visual acuity at three months
Best corrected visual acuity of participants after surgery at three months
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Time frame: three months
Best corrected visual acuity at six months
Best corrected visual acuity of participants after surgery at six months
Time frame: six months
Best corrected visual acuity at one year
Best corrected visual acuity of participants after surgery at one year
Time frame: one year
Best corrected visual acuity at two years
Best corrected visual acuity of participants after surgery at two years
Time frame: two years
Best corrected visual acuity at three years
Best corrected visual acuity of participants after surgery at three years
Time frame: three years
Mean deviation
The mean deviation value of Humphery visual filed tests before and after surgery.
Time frame: one month, three months, six months, one year, two years, three years
The thickness of retinal nerve fiber layer (RNFL)
The RNFL thickness measured by optical coherence topography (OCT)
Time frame: one month, three months, six months, one year, two years, three years
The thickness of ganglion cell complex (GCC)
The GCC thickness measured by OCT
Time frame: one month, three months, six months, one year, two years, three years
Number of eye drops
The number of eye drops after surgery.
Time frame: one month, three months, six months, one year, two years, three years
Adverse event
Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage
Time frame: one month, three months, six months, one year, two years, three years