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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
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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