Glaucoma, Angle-ClosureNCT01298635
Comparison of Phacotrabeculectomy and Trabeculectomy in the Treatment of Primary Angle-closure Glaucoma (PACG)
A study testing combined phacotrabeculectomy and trabeculectomy in people with Glaucoma, Angle-Closure and Cataract, run by Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 82 years
- Conditions the study is for
- Glaucoma, Angle-Closure, Cataract
- What is being tested?
- combined phacotrabeculectomy and trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary angle-closure glaucoma with co-existing cataract
Who cannot join
- secondary glaucoma
- history of any intraocular surgery, including laser iridectomy
About this study
Official title: 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.
- Conditions
- Glaucoma, Angle-Closure, Cataract
- Being tested
- combined phacotrabeculectomy, trabeculectomy
- Keywords
- Primary angle-closure glaucoma, cataract, trabeculectomy, phacotrabeculectomy
- Medical subject headings
- Glaucoma, Angle-Closure, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined phacotrabeculectomyProcedure or surgery
trabeculectomy plus phacoemulsification with intraocular lens implantation
trabeculectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| trab | Active comparator | Not described Receives: Procedure: trabeculectomy |
| phacotrab | Active comparator | Not described Receives: Procedure: combined phacotrabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of intraocular pressure
the difference of intraocular pressure between preoperation and postopration at the last followup
Measured: within 18 months after surgery
Secondary outcomes (4)
Number of Glaucoma medications
to compare the number of pre- and post-operative intraocular pressure lowering drugs
Measured: 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
Measured: 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.
Measured: 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
Measured: within 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Angle-ClosureStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Guangdong Province, Department of Science and Technology
- Investigators
- Jian Ge, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298635
- Sponsor's protocol ID
- GJ-PACG-phacotrab/trab
- Status last verified
- Nov 2004
- First submitted
- 17 Feb 2011
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12770969Gelber EC, Anderson DR. Surgical decisions in chronic angle-closure glaucoma. Arch Ophthalmol. 1976 Sep;94(9):1481-4. doi: 10.1001/archopht.1976.03910040315004.
PubMed 962659Sihota 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.
PubMed 14746586Hong 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.
PubMed 17947826Zhang 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.
PubMed 17867508Wang 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.
PubMed 19575967Tsai 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.
PubMed 19383599Wishart 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.
PubMed 2630350Acton 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.
PubMed 9292680Gunning 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.
PubMed 9795850Hayashi 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.
PubMed 11709251Liu 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.
PubMed 17030705Tham 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.
PubMed 19243831Tham 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.
PubMed 18801576Zhuo 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.
PubMed 20010241
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combined Phacotrabeculectomy and Trabeculectomy Only in the Treatment of Primary Angle-closure Glaucoma
- ClinicalTrials.gov ID
- NCT01298635
- Acronym / sponsor ID
- GJ-PACG-phacotrab/trab
- Conditions
- Glaucoma, Angle-Closure, Cataract
- Keywords
- Primary angle-closure glaucoma, cataract, trabeculectomy, phacotrabeculectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Guangdong Province, Department of Science and Technology
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trab | Active comparator | Procedure: trabeculectomy |
| phacotrab | Active comparator | Procedure: combined phacotrabeculectomy |
Who may qualify
- Ages
- 40 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of primary angle-closure glaucoma with co-existing cataract
Key exclusion criteria (2 listed)
- secondary glaucoma
- history of any intraocular surgery, including laser iridectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined phacotrabeculectomytrabeculectomy plus phacoemulsification with intraocular lens implantation | Procedure or surgery | phacotrab |
| trabeculectomy | Procedure or surgery | trab |
Primary outcome
reduction of intraocular pressure
Time frame: within 18 months after surgery
the difference of intraocular pressure between preoperation and postopration at the last followup
4 secondary outcomes
Number of Glaucoma medications
Time frame: within 18 months after surgery
Morphology of filtering blebs
Time frame: within 18 months after surgery
Visual outcomes
Time frame: within 18 months after surgery
number of eyes with complications during and after surgery
Time frame: within 18 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
- Background: PubMed 12770969Gazzard 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.
- Background: PubMed 962659Gelber EC, Anderson DR. Surgical decisions in chronic angle-closure glaucoma. Arch Ophthalmol. 1976 Sep;94(9):1481-4. doi: 10.1001/archopht.1976.03910040315004.
- Background: PubMed 14746586Sihota 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.
- Background: PubMed 17947826Hong 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.
- Background: PubMed 17867508Zhang 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.
- Background: PubMed 19575967Wang 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.
- Background: PubMed 19383599Tsai 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.
- Background: PubMed 2630350Wishart 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.
- Background: PubMed 9292680Acton 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.
- Background: PubMed 9795850Gunning 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.
- Background: PubMed 11709251Hayashi 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.
- Background: PubMed 17030705Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Ge, MD, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing combined phacotrabeculectomy and trabeculectomy in people with Glaucoma, Angle-Closure and Cataract, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of intraocular pressure (time frame: within 18 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01298635, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.