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

NCT01298635 | Completed DMC

• 1 other identifier: GJ-PACG-phacotrab/trab
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glaucoma, Angle-Closure; Cataract

Keywords

Primary angle-closure glaucoma; cataract; trabeculectomy; phacotrabeculectomy

Outcome Measures

Primary Outcomes (1)

• reduction of intraocular pressure

  the difference of intraocular pressure between preoperation and postopration at the last followup

  within 18 months after surgery

Secondary Outcomes (4)

• Number of Glaucoma medications

  within 18 months after surgery

• Morphology of filtering blebs

  within 18 months after surgery

• Visual outcomes

  within 18 months after surgery

• number of eyes with complications during and after surgery

  within 18 months after surgery

Study Arms (2)

trab

ACTIVE COMPARATOR

Procedure: trabeculectomy

phacotrab

ACTIVE COMPARATOR

Procedure: combined phacotrabeculectomy

Interventions

combined phacotrabeculectomy PROCEDURE

trabeculectomy plus phacoemulsification with intraocular lens implantation

phacotrab

trabeculectomy PROCEDURE

trab

Eligibility Criteria

• Age: 40 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• secondary glaucoma
• history of any intraocular surgery, including laser iridectomy

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Science and Technology: collaborator
• Guangdong Province, Department of Science and Technology: collaborator

Related Publications (24)

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MeSH Terms

Conditions

Glaucoma, Angle-Closure; Cataract

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jian Ge, MD, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: January 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 18, 2011

Record last verified: 2004-11