An interventional study of ab interno trabeculectomy with Trabectome and trabeculectomy in Glaucoma, Angle-Closure, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-28.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Treatment
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 .
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 246 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.
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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
PACG in AIT group will receive trabeculectomy.
Procedure: trabeculectomy
123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly
123 PACG will be recruited to receive trabeculectomy to reduce IOP
success rate of IOP reduction
IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery
Time frame: 12 months
number of antiglaucoma medication
numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.
Time frame: 12 months
complication rate
all the complications related to the surgery will be evaluated and recorded.
Time frame: 12 months
24-hour IOP fluctuations
24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Shanghai Eye Disease Prevention and Treatment Center