Comparison of Phacotrabeculectomy and Trabeculectomy in the Treatment of Primary Angle-closure Glaucoma (PACG)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Science and Technology
Guangdong Province, Department of Science and Technology
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01298635
First received: February 17, 2011
Last updated: NA
Last verified: November 2004
History: No changes posted

February 17, 2011
February 17, 2011
January 2005
January 2007   (final data collection date for primary outcome measure)
reduction of intraocular pressure [ Time Frame: within 18 months after surgery ] [ Designated as safety issue: No ]
the difference of intraocular pressure between preoperation and postopration at the last followup
Same as current
No Changes Posted
  • Number of Glaucoma medications [ Time Frame: within 18 months after surgery ] [ Designated as safety issue: No ]
    to compare the number of pre- and post-operative intraocular pressure lowering drugs
  • Morphology of filtering blebs [ Time Frame: within 18 months after surgery ] [ Designated as safety issue: No ]
    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
  • Visual outcomes [ Time Frame: within 18 months after surgery ] [ Designated as safety issue: No ]
    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.
  • number of eyes with complications during and after surgery [ Time Frame: within 18 months after surgery ] [ Designated as safety issue: Yes ]
    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
Same as current
Not Provided
Not Provided
 
Comparison of Phacotrabeculectomy and Trabeculectomy in the Treatment of Primary Angle-closure Glaucoma (PACG)
Comparison of Combined Phacotrabeculectomy and Trabeculectomy Only in the Treatment of Primary Angle-closure Glaucoma

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma, Angle-Closure
  • Cataract
  • Procedure: combined phacotrabeculectomy
    trabeculectomy plus phacoemulsification with intraocular lens implantation
  • Procedure: trabeculectomy
  • Active Comparator: trab
    Intervention: Procedure: trabeculectomy
  • Active Comparator: phacotrab
    Intervention: Procedure: combined phacotrabeculectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
May 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of primary angle-closure glaucoma with co-existing cataract

Exclusion Criteria:

  • secondary glaucoma
  • history of any intraocular surgery, including laser iridectomy
Both
40 Years to 82 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01298635
GJ-PACG-phacotrab/trab
Yes
Jian Ge, Zhongshan Ophthalmic Center
Sun Yat-sen University
  • Ministry of Science and Technology
  • Guangdong Province, Department of Science and Technology
Principal Investigator: Jian Ge, MD, PhD Zhongshan Ophthalmic Center, Sun Yat-sen University
Sun Yat-sen University
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP