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

Glaucoma, Angle-Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02964676
• Other study ID #: YFZX2016002
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2016
• Last updated: November 23, 2016
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: LING GE, M.d.
• Phone: +86-21-62717733
• Email: geling99[@]sina.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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 .

Description:

A randomized, single blind, positive parallel control study method was used.This prospective case series will recruit 246 Chinese POAG, 123 cases in the experimental group will receive AIT treatment and 123 cases in the control group will receive trabeculectomy(Trab) surgery.Measurements of intraocular pressure(IOP) , visual acuity, refraction, slit lamp examination of the anterior segment and fundus, optical coherence tomography(OCT) to detect retinal nerve fiber layer thickness, macular thickness, visual field, gonioscopy and ultrasonic biological microscopy (UBM) will be recorded.They will be followed up for 12 months. The main outcome is success rate of IOP reduction and the other outcome are the number of antiglaucoma medication and complications .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 246
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lee JW, Yick DW, Tsang S, Yuen CY, Lai JS. Efficacy and Safety of Trabectome Surgery in Chinese Open-Angle Glaucoma. Medicine (Baltimore). 2016 Apr;95(15):e3212. doi: 10.1097/MD.0000000000003212. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View 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. — View Citation

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. — View 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. — View Citation

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

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. — View Citation

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. — View 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. — View Citation

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. German. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of IOP reduction	IOP =21mmHg and IOP reduction rate =20% with or without antiglaucoma medications and without additional glaucoma surgery	12 months	No
Secondary	number of antiglaucoma medication	numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.	12 months	No
Secondary	complication rate	all the complications related to the surgery will be evaluated and recorded.	12 months	Yes
Secondary	24-hour IOP fluctuations	24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.	12 months	No