Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma

NCT02964676 | Unknown

• 1 other identifier: YFZX2016002
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG .

Conditions

Glaucoma, Angle-Closure

Outcome Measures

Primary Outcomes (1)

• success rate of IOP reduction

  IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery

  12 months

Secondary Outcomes (3)

• number of antiglaucoma medication

  12 months

• complication rate

  12 months

• 24-hour IOP fluctuations

  12 months

Study Arms (2)

AIT group

EXPERIMENTAL

PACG in AIT group will receive ab interno trabeculectomy with Trabectome and before AIT, Laser Peripheral Iridectomy (LPI) will be performed first.

Procedure: ab interno trabeculectomy with Trabectome

Trab group

ACTIVE COMPARATOR

PACG in AIT group will receive trabeculectomy.

Procedure: trabeculectomy

Interventions

ab interno trabeculectomy with Trabectome PROCEDURE

123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly

AIT group

trabeculectomy PROCEDURE

123 PACG will be recruited to receive trabeculectomy to reduce IOP

Trab group

Eligibility Criteria

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

You may qualify if:

• Primary Angle Closure Glaucoma (PACG) with visible trabecular meshwork from 90︒ to 180︒ on gonioscopy and IOP couldn't be controlled ≤21mmHg with pilocarpine eye drop only.
• willing to accept the antiglaucoma surgery
• volunteer to participate in this study and be able to follow up on time
• previous antiglaucoma filtering surgery or laser surgery(LPI, SLT) and previous cataract surgery were not ruled out

You may not qualify if:

• visual acuity lower than HM or central tubular visual field
• corneal edema or large pterygium affecting the observation of anterior angle
• the demarcation of the scleral process and trabecular meshwork is not clear on gonioscopy
• new vessels on the iris surface or in the anterior angle chamber
• the eye received surgery is the only eye with visual function, that is the contralateral eye is blind
• requiring long-term use of anticoagulant drugs for systemic reasons
• abnormal coagulation function
• with specific clear scar physique
• cannot participate in follow-up

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Related Publications (23)

• He M, Foster PJ, Ge J, Huang W, Zheng Y, Friedman DS, Lee PS, Khaw PT. Prevalence and clinical characteristics of glaucoma in adult Chinese: a population-based study in Liwan District, Guangzhou. Invest Ophthalmol Vis Sci. 2006 Jul;47(7):2782-8. doi: 10.1167/iovs.06-0051.

  PMID: 16799014 BACKGROUND

• Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.

  PMID: 12049574 BACKGROUND

• Palanca-Capistrano AM, Hall J, Cantor LB, Morgan L, Hoop J, WuDunn D. Long-term outcomes of intraoperative 5-fluorouracil versus intraoperative mitomycin C in primary trabeculectomy surgery. Ophthalmology. 2009 Feb;116(2):185-90. doi: 10.1016/j.ophtha.2008.08.009. Epub 2008 Oct 18.

  PMID: 18930550 BACKGROUND

• Wang M, Fang M, Bai YJ, Zhang WZ, Lin MK, Liu BQ, Hao YT, Ling YL, Zhuo YH, Ge J. Comparison of combined phacotrabeculectomy with trabeculectomy only in the treatment of primary angle-closure glaucoma. Chin Med J (Engl). 2012 Apr;125(8):1429-33.

  PMID: 22613648 BACKGROUND

• Wagn X, Jia C, Feng MY, Meng HL, Fan SJ, Xie LL, Sun LP, Liu LR, Xie C, Peng Y, Tang X, Liagn YB, Zhai G, Jiang YQ, Ye TC, Wang NL. [Assess correlation between bleb morphology at long-term intraocular pressure effect in primary angle-closure glaucoma following trabeculectomy]. Zhonghua Yan Ke Za Zhi. 2011 Oct;47(10):898-902. Chinese.

  PMID: 22321499 BACKGROUND

• 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.

  PMID: 19575967 BACKGROUND

• 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.

  PMID: 14746586 BACKGROUND

• 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.

  PMID: 19383599 BACKGROUND

• Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003 Sep;136(3):464-70. doi: 10.1016/s0002-9394(03)00239-3.

  PMID: 12967799 BACKGROUND

• Soltau JB, Rothman RF, Budenz DL, Greenfield DS, Feuer W, Liebmann JM, Ritch R. Risk factors for glaucoma filtering bleb infections. Arch Ophthalmol. 2000 Mar;118(3):338-42. doi: 10.1001/archopht.118.3.338.

  PMID: 10721955 BACKGROUND

• DeBry PW, Perkins TW, Heatley G, Kaufman P, Brumback LC. Incidence of late-onset bleb-related complications following trabeculectomy with mitomycin. Arch Ophthalmol. 2002 Mar;120(3):297-300. doi: 10.1001/archopht.120.3.297.

  PMID: 11879132 BACKGROUND

• Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104. doi: 10.1097/ICU.0b013e32834ff1e7.

  PMID: 22249233 BACKGROUND

• Ho CL, Lai JS, Aquino MV, Rojanapongpun P, Wong HT, Aquino MC, Gerber Y, Belkin M, Barkana Y. Selective laser trabeculoplasty for primary angle closure with persistently elevated intraocular pressure after iridotomy. J Glaucoma. 2009 Sep;18(7):563-6. doi: 10.1097/IJG.0b013e318193c2d1.

  PMID: 19745672 BACKGROUND

• Mosaed S, Dustin L, Minckler DS. Comparative outcomes between newer and older surgeries for glaucoma. Trans Am Ophthalmol Soc. 2009 Dec;107:127-33.

  PMID: 20126489 RESULT

• Minckler D, Mosaed S, Dustin L, Ms BF; Trabectome Study Group. Trabectome (trabeculectomy-internal approach): additional experience and extended follow-up. Trans Am Ophthalmol Soc. 2008;106:149-59; discussion 159-60.

  PMID: 19277230 RESULT

• Vinod K, Gedde SJ. Ab interno trabeculectomy: patient selection and perspectives. Clin Ophthalmol. 2016 Aug 17;10:1557-64. doi: 10.2147/OPTH.S99746. eCollection 2016.

  PMID: 27574396 RESULT

• Minckler D, Baerveldt G, Ramirez MA, Mosaed S, Wilson R, Shaarawy T, Zack B, Dustin L, Francis B. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma. Trans Am Ophthalmol Soc. 2006;104:40-50.

  PMID: 17471324 RESULT

• Maeda M, Watanabe M, Ichikawa K. Evaluation of trabectome in open-angle glaucoma. J Glaucoma. 2013 Mar;22(3):205-8. doi: 10.1097/IJG.0b013e3182311b92.

  PMID: 23429629 RESULT

• Werth JP, Gesser C, Klemm M. [Diverse effectiveness of the trabectome for different types of glaucoma]. Klin Monbl Augenheilkd. 2015 Jan;232(1):72-8. doi: 10.1055/s-0034-1383010. Epub 2014 Oct 1. German.

  PMID: 25272084 RESULT

• Lee JWY, Yick DWF, Tsang S, Yuen CYF, Lai JSM. Efficacy and Safety of Trabectome Surgery in Chinese Open-Angle Glaucoma. Medicine (Baltimore). 2016 Apr;95(15):e3212. doi: 10.1097/MD.0000000000003212.

  PMID: 27082559 RESULT

• Jea SY, Mosaed S, Vold SD, Rhee DJ. Effect of a failed trabectome on subsequent trabeculectomy. J Glaucoma. 2012 Feb;21(2):71-5. doi: 10.1097/IJG.0b013e31820bcfda.

  PMID: 21336149 RESULT

• Huang P, Wang H, Wu H, Sun Y, Wang M, Cui Y, Qiu W, Yang Y, Ren Z, Zhang C, Wang N. [Preliminary investigation on the safety and efficacy of Trabectome]. Zhonghua Yan Ke Za Zhi. 2015 Feb;51(2):115-9. Chinese.

  PMID: 25908002 RESULT

• Bussel II, Kaplowitz K, Schuman JS, Loewen NA; Trabectome Study Group. Outcomes of ab interno trabeculectomy with the trabectome by degree of angle opening. Br J Ophthalmol. 2015 Jul;99(7):914-9. doi: 10.1136/bjophthalmol-2014-305577. Epub 2014 Oct 21.

  PMID: 25336577 RESULT

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• LING GE, M.d.

  Shanghai Eye Disease Prevention and Treatment Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LING GE, M.d.

CONTACT

+86-21-62717733; geling99@sina.com

XIAOLING FANG, M.d.

CONTACT

+86-21-62717733; fangxl0617@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 28, 2016

Record last verified: 2016-11