Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma
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|ClinicalTrials.gov Identifier: NCT02964676|
Recruitment Status : Not yet recruiting
First Posted : November 16, 2016
Last Update Posted : November 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Angle-Closure||Procedure: ab interno trabeculectomy with Trabectome Procedure: trabeculectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||246 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Chinese Primary Angle Closure Glaucoma|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: AIT group
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
123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly
Active Comparator: Trab group
PACG in AIT group will receive trabeculectomy.
123 PACG will be recruited to receive trabeculectomy to reduce IOP
- success rate of IOP reduction [ Time Frame: 12 months ]IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery
- number of antiglaucoma medication [ Time Frame: 12 months ]numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.
- complication rate [ Time Frame: 12 months ]all the complications related to the surgery will be evaluated and recorded.
- 24-hour IOP fluctuations [ Time Frame: 12 months ]24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964676
|Contact: LING GE, M.d.||+86-21-62717733 ext firstname.lastname@example.org|
|Contact: XIAOLING FANG, M.d.||+86-21-62717733 ext email@example.com|
|Principal Investigator:||LING GE, M.d.||Shanghai Eye Disease Prevention and Treatment Center|