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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 .
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Trab group | Active Comparator | PACG in AIT group will receive trabeculectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of IOP reduction | IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of antiglaucoma medication | numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up. | 12 months |
| complication rate | all the complications related to the surgery will be evaluated and recorded. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LING GE, M.d. | Contact | +86-21-62717733 | 851 | geling99@sina.com |
| XIAOLING FANG, M.d. | Contact | +86-21-62717733 | 811 | fangxl0617@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| LING GE, M.d. | Shanghai Eye Disease Prevention and Treatment Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16799014 | Background | 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. | |
| 12049574 | 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. |
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| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| trabeculectomy | Procedure | 123 PACG will be recruited to receive trabeculectomy to reduce IOP |
|
| 12 months |
| 24-hour IOP fluctuations | 24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up. | 12 months |
| 18930550 | 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. |
| 22613648 | 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. |
| 22321499 | 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. |
| 19575967 | 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. |
| 14746586 | 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. |
| 19383599 | 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. |
| 12967799 | 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. |
| 10721955 | 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. |
| 11879132 | 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. |
| 22249233 | 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. |
| 19745672 | 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. |
| 20126489 | Result | Mosaed S, Dustin L, Minckler DS. Comparative outcomes between newer and older surgeries for glaucoma. Trans Am Ophthalmol Soc. 2009 Dec;107:127-33. |
| 19277230 | 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. |
| 27574396 | 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. |
| 17471324 | 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. |
| 23429629 | 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. |
| 25272084 | 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. |
| 27082559 | 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. |
| 21336149 | 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. |
| 25908002 | 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. |
| 25336577 | 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. |