An interventional study of combined phacotrabeculectomy and trabeculectomy in Glaucoma, Angle-Closure and Cataract, sponsored by Sun Yat-sen University. Completed. Open to participants aged 40 Years to 82 Years. Per ClinicalTrials.gov, last updated 2011-02-18.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
Primary angle closure glaucoma (PACG) is caused by contact between the iris and trabecular meshwork, which in turn obstructs outflow of the aqueous humor from the eye. This contact between iris and trabecular meshwork (TM) may gradually damage the function of the meshwork until it fails to keep pace with aqueous production, and the pressure rises, and at last the optic nerve is damaged, the vision may be lost in some severe cases. Therefore, ocular pressure reduction is the key to treat the disease and prevent blindness. Trabeculectomy is the most common conventional surgery performed for glaucoma. This allows fluid to flow out of the eye through this opening, resulting in lowered intraocular pressure(IOP) and the formation of a bleb or fluid bubble on the surface of the eye.
Cataract surgery is common in the elderly. Cataract surgery is the removal of the natural lens of the eye (also called "crystalline lens") that has developed an opacification, which is referred to as a cataract. Cataract extraction includes intracapsular cataract extraction, extra capsular cataract extraction \& phacoemulsification, and phacoemulsification is the preferred method. It has been reported that IOP reduction could occur in cataract patients with PACG after the cataract surgery. For some cases with PACG, such IOP reduction may be insufficient for neuronal protection, and many patients still require glaucoma medication and incisional surgery such as trabeculectomy to control IOP. In such cases, a combined cataract-glaucoma procedure (phacotrabeculectomy) is a reasonable option. In keeping with this concept, previous studies have shown that phacotrabeculectomy could effectively and simultaneously reduce IOP and improve vision in patients with a coexistence of PACG and vision-threatening cataract. However, phacotrabeculectomy may heighten inflammatory response, result in a higher frequency of postoperative complications such as hyphema and fibrin in the anterior chamber, endophthalmitis, and increased scarring of the filtering bleb. Thus, it is unclear whether phacotrabeculectomy is as effective and safe as trabeculectomy in lowering IOP for PACG patients.
In the present study, the investigators compared the efficacy and safety of phacotrabeculectomy and trabeculectomy in patients with coexisting PACG and cataract.
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This study's enrollment of 31 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Procedure: trabeculectomy
Procedure: combined phacotrabeculectomy
trabeculectomy plus phacoemulsification with intraocular lens implantation
reduction of intraocular pressure
the difference of intraocular pressure between preoperation and postopration at the last followup
Time frame: within 18 months after surgery
Number of Glaucoma medications
to compare the number of pre- and post-operative intraocular pressure lowering drugs
Time frame: within 18 months after surgery
Morphology of filtering blebs
The filtering bleb morphology was assessed using simplified the Indiana bleb assessment grading system with a slit-lamp.Then to analyze the number of eyes with different type of blebs
Time frame: within 18 months after surgery
Visual outcomes
best corrected visual acuity was measured on Snellen decimal charts and subsequently converted to the logarithm of the minimal angle of resolution (logMAR) for analysis.
Time frame: within 18 months after surgery
number of eyes with complications during and after surgery
number of eyes with different complications such as shallow anterior chamber, malignant glaucoma,hyphema, Exudation in the anterior chamber,Corneal edema,Choroidal detachment,intraocular pressure spike on postoperative day 1
Time frame: within 18 months after surgery
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This study is completed, as verified in Nov 2004. You cannot join it, but the record below documents what was studied.
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