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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
Sponsor:
Information provided by (Responsible Party):
Shanghai Eye Disease Prevention and Treatment Center

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 .

Condition or disease Intervention/treatment Phase
Glaucoma, Angle-Closure Procedure: ab interno trabeculectomy with Trabectome Procedure: trabeculectomy Not Applicable

Detailed 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 .

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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.
Procedure: trabeculectomy
123 PACG will be recruited to receive trabeculectomy to reduce IOP




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. number of antiglaucoma medication [ Time Frame: 12 months ]
    numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.

  2. complication rate [ Time Frame: 12 months ]
    all the complications related to the surgery will be evaluated and recorded.

  3. 24-hour IOP fluctuations [ Time Frame: 12 months ]
    24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: LING GE, M.d. +86-21-62717733 ext 851 geling99@sina.com
Contact: XIAOLING FANG, M.d. +86-21-62717733 ext 811 fangxl0617@hotmail.com

Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Investigators
Principal Investigator: LING GE, M.d. Shanghai Eye Disease Prevention and Treatment Center

Publications of Results:

Other Publications:

Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT02964676     History of Changes
Other Study ID Numbers: YFZX2016002
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases