Comparison of Phacotrabeculectomy and Trabeculectomy in the Treatment of Primary Angle-closure Glaucoma (PACG)
Primary Purpose
Glaucoma, Angle-Closure, Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
combined phacotrabeculectomy
trabeculectomy
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Angle-Closure focused on measuring Primary angle-closure glaucoma, cataract, trabeculectomy, phacotrabeculectomy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
trab
phacotrab
Arm Description
Outcomes
Primary Outcome Measures
reduction of intraocular pressure
the difference of intraocular pressure between preoperation and postopration at the last followup
Secondary Outcome Measures
Number of Glaucoma medications
to compare the number of pre- and post-operative intraocular pressure lowering drugs
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
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.
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
Full Information
NCT ID
NCT01298635
First Posted
February 17, 2011
Last Updated
February 17, 2011
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Science and Technology, Guangdong Province, Department of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01298635
Brief Title
Comparison of Phacotrabeculectomy and Trabeculectomy in the Treatment of Primary Angle-closure Glaucoma (PACG)
Official Title
Comparison of Combined Phacotrabeculectomy and Trabeculectomy Only in the Treatment of Primary Angle-closure Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Science and Technology, Guangdong Province, Department of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-Closure, Cataract
Keywords
Primary angle-closure glaucoma, cataract, trabeculectomy, phacotrabeculectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trab
Arm Type
Active Comparator
Arm Title
phacotrab
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
combined phacotrabeculectomy
Intervention Description
trabeculectomy plus phacoemulsification with intraocular lens implantation
Intervention Type
Procedure
Intervention Name(s)
trabeculectomy
Primary Outcome Measure Information:
Title
reduction of intraocular pressure
Description
the difference of intraocular pressure between preoperation and postopration at the last followup
Time Frame
within 18 months after surgery
Secondary Outcome Measure Information:
Title
Number of Glaucoma medications
Description
to compare the number of pre- and post-operative intraocular pressure lowering drugs
Time Frame
within 18 months after surgery
Title
Morphology of filtering blebs
Description
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
Title
Visual outcomes
Description
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
Title
number of eyes with complications during and after surgery
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Ge, MD, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
12770969
Citation
Gazzard G, Foster PJ, Devereux JG, Oen F, Chew P, Khaw PT, Seah S. Intraocular pressure and visual field loss in primary angle closure and primary open angle glaucomas. Br J Ophthalmol. 2003 Jun;87(6):720-5. doi: 10.1136/bjo.87.6.720.
Results Reference
background
PubMed Identifier
962659
Citation
Gelber EC, Anderson DR. Surgical decisions in chronic angle-closure glaucoma. Arch Ophthalmol. 1976 Sep;94(9):1481-4. doi: 10.1001/archopht.1976.03910040315004.
Results Reference
background
PubMed Identifier
14746586
Citation
Sihota R, Gupta V, Agarwal HC. Long-term evaluation of trabeculectomy in primary open angle glaucoma and chronic primary angle closure glaucoma in an Asian population. Clin Exp Ophthalmol. 2004 Feb;32(1):23-8. doi: 10.1046/j.1442-9071.2004.00752.x.
Results Reference
background
PubMed Identifier
17947826
Citation
Hong S, Park K, Ha SJ, Yeom HY, Seong GJ, Hong YJ. Long-term intraocular pressure control of trabeculectomy and triple procedure in primary open angle glaucoma and chronic primary angle closure glaucoma. Ophthalmologica. 2007;221(6):395-401. doi: 10.1159/000107499.
Results Reference
background
PubMed Identifier
17867508
Citation
Zhang X, Teng L, Li A, Du S, Zhu Y, Ge J. The clinical outcomes of three surgical managements on primary angle-closure glaucoma. Yan Ke Xue Bao. 2007 Jun;23(2):65-74.
Results Reference
background
PubMed Identifier
19575967
Citation
Wang M, Ge J, Lin MK, Zhuo YH, Ling YL, Fang M, Liu X, Peng SX, Yu MB. [Clinical observation of trabeculectomy for primary angle closure glaucoma]. Zhonghua Yan Ke Za Zhi. 2009 Apr;45(4):338-43. Chinese.
Results Reference
background
PubMed Identifier
19383599
Citation
Tsai HY, Liu CJ, Cheng CY. Combined trabeculectomy and cataract extraction versus trabeculectomy alone in primary angle-closure glaucoma. Br J Ophthalmol. 2009 Jul;93(7):943-8. doi: 10.1136/bjo.2008.151803. Epub 2009 Apr 20.
Results Reference
background
PubMed Identifier
2630350
Citation
Wishart PK, Atkinson PL. Extracapsular cataract extraction and posterior chamber lens implantation in patients with primary chronic angle-closure glaucoma: effect on intraocular pressure control. Eye (Lond). 1989;3 ( Pt 6):706-12. doi: 10.1038/eye.1989.109.
Results Reference
background
PubMed Identifier
9292680
Citation
Acton J, Salmon JF, Scholtz R. Extracapsular cataract extraction with posterior chamber lens implantation in primary angle-closure glaucoma. J Cataract Refract Surg. 1997 Jul-Aug;23(6):930-4. doi: 10.1016/s0886-3350(97)80255-6.
Results Reference
background
PubMed Identifier
9795850
Citation
Gunning FP, Greve EL. Lens extraction for uncontrolled angle-closure glaucoma: long-term follow-up. J Cataract Refract Surg. 1998 Oct;24(10):1347-56. doi: 10.1016/s0886-3350(98)80227-7.
Results Reference
background
PubMed Identifier
11709251
Citation
Hayashi K, Hayashi H, Nakao F, Hayashi F. Effect of cataract surgery on intraocular pressure control in glaucoma patients. J Cataract Refract Surg. 2001 Nov;27(11):1779-86. doi: 10.1016/s0886-3350(01)01036-7.
Results Reference
background
PubMed Identifier
17030705
Citation
Liu CJ, Cheng CY, Wu CW, Lau LI, Chou JC, Hsu WM. Factors predicting intraocular pressure control after phacoemulsification in angle-closure glaucoma. Arch Ophthalmol. 2006 Oct;124(10):1390-4. doi: 10.1001/archopht.124.10.1390.
Results Reference
background
PubMed Identifier
19243831
Citation
Tham CC, Kwong YY, Leung DY, Lam SW, Li FC, Chiu TY, Chan JC, Lam DS, Lai JS. Phacoemulsification versus combined phacotrabeculectomy in medically uncontrolled chronic angle closure glaucoma with cataracts. Ophthalmology. 2009 Apr;116(4):725-31, 731.e1-3. doi: 10.1016/j.ophtha.2008.12.054. Epub 2009 Feb 25.
Results Reference
background
PubMed Identifier
18801576
Citation
Tham CC, Kwong YY, Leung DY, Lam SW, Li FC, Chiu TY, Chan JC, Chan CH, Poon AS, Yick DW, Chi CC, Lam DS, Lai JS. Phacoemulsification versus combined phacotrabeculectomy in medically controlled chronic angle closure glaucoma with cataract. Ophthalmology. 2008 Dec;115(12):2167-2173.e2. doi: 10.1016/j.ophtha.2008.06.016. Epub 2008 Sep 18.
Results Reference
background
PubMed Identifier
20010241
Citation
Zhuo YH, Wang M, Li Y, Hao YT, Lin MK, Fang M, Ge J. Phacoemulsification treatment of subjects with acute primary angle closure and chronic primary angle-closure glaucoma. J Glaucoma. 2009 Dec;18(9):646-51. doi: 10.1097/IJG.0b013e31819c4322.
Results Reference
background
PubMed Identifier
7722902
Citation
Wedrich A, Menapace R, Radax U, Papapanos P. Long-term results of combined trabeculectomy and small incision cataract surgery. J Cataract Refract Surg. 1995 Jan;21(1):49-54. doi: 10.1016/s0886-3350(13)80479-8.
Results Reference
background
PubMed Identifier
9076202
Citation
Park HJ, Weitzman M, Caprioli J. Temporal corneal phacoemulsification combined with superior trabeculectomy. A retrospective case-control study. Arch Ophthalmol. 1997 Mar;115(3):318-23. doi: 10.1001/archopht.1997.01100150320002.
Results Reference
background
PubMed Identifier
9753949
Citation
Kim JW, Jung CI, Hwang HS. Comparative study of three phacotrabeculectomy procedures through a single incision. Korean J Ophthalmol. 1998 Jun;12(1):30-6. doi: 10.3341/kjo.1998.12.1.30.
Results Reference
background
PubMed Identifier
10695203
Citation
Wu WC, Wu SC, Lin SM. Surgical outcome of combined phacoemulsification and trabeculectomy. Changgeng Yi Xue Za Zhi. 1999 Dec;22(4):572-8.
Results Reference
background
PubMed Identifier
14531631
Citation
Tow SL, Aung T, Oen FT, Seah SK. Combined phacoemulsification, intraocular lens implantation and trabeculectomy for chronic angle closure glaucoma. Int Ophthalmol. 2001;24(5):283-9. doi: 10.1023/a:1025478923950.
Results Reference
background
PubMed Identifier
11942540
Citation
Kleinmann G, Katz H, Pollack A, Schechtman E, Rachmiel R, Zalish M. Comparison of trabeculectomy with mitomycin C with or without phacoemulsification and lens implantation. Ophthalmic Surg Lasers. 2002 Mar-Apr;33(2):102-8.
Results Reference
background
PubMed Identifier
15295672
Citation
Lai JS, Tham CC, Chan JC, Lam DS. Phacotrabeculectomy in treatment of primary angle-closure glaucoma and primary open-angle glaucoma. Jpn J Ophthalmol. 2004 Jul-Aug;48(4):408-11. doi: 10.1007/s10384-003-0075-2.
Results Reference
background
PubMed Identifier
17081897
Citation
Zarei R, Azimi R, Moghimi S, Abdollahi A, Amini H, Eslami Y, Fakhraii G. Inhibition of intraocular fibrin formation after infusion of low-molecular-weight heparin during combined phacoemulsification-trabeculectomy surgery. J Cataract Refract Surg. 2006 Nov;32(11):1921-5. doi: 10.1016/j.jcrs.2006.06.029.
Results Reference
background
PubMed Identifier
12782847
Citation
Cantor LB, Mantravadi A, WuDunn D, Swamynathan K, Cortes A. Morphologic classification of filtering blebs after glaucoma filtration surgery: the Indiana Bleb Appearance Grading Scale. J Glaucoma. 2003 Jun;12(3):266-71. doi: 10.1097/00061198-200306000-00015.
Results Reference
background
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Comparison of Phacotrabeculectomy and Trabeculectomy in the Treatment of Primary Angle-closure Glaucoma (PACG)
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