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Trial record 1 of 3 for:    xiulan zhang
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Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by xiulan zhang, Sun Yat-sen University
Sponsor:
Collaborators:
Beijing Tongren Hospital
Wenzhou Medical University
The Second Affiliated Hospital of Harbin Medical University
Huazhong University of Science and Technology
The Third Hospital of HanDan
Third Affiliated Hospital of Third Military Medical University
Central South University
He University
Hebei Provincial Eye Hospital
Information provided by (Responsible Party):
xiulan zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02613013
First received: November 5, 2015
Last updated: November 17, 2016
Last verified: November 2016
  Purpose
This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to control the progression of primary angle closure with multi-mechanism based on the UBM classification.

Condition Intervention
Glaucoma, Angle-Closure Device: neodymium:yttrium-aluminum- garnet laser Device: frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser Drug: Pilocarpine Procedure: LPIP plus LPI Drug: Proparacaine Procedure: LPI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure With Multi-mechanism Based on UBM: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by xiulan zhang, Sun Yat-sen University:

Primary Outcome Measures:
  • Progression rate determined by number of patients who progress after laser treatment for each group. [ Time Frame: 3 years ]

    PAC progression defined as presence of any of the following:

    1. Acute angle closure crisis
    2. Intraocular (IOP) was 8mmHg higher than initiation 1 month after the laser procedure
    3. IOP was ≥22mmHg when measured three times of continuous 1 month after the lase procedure
    4. The progression of peripheral anterior synechiae ≥ 1 clock hour within 3 years after the laser procedure as measured by gonioscopic examination.
    5. glaucomatous neuropathy within 3 years after the laser procedure


Secondary Outcome Measures:
  • Additional medication or surgery required questionnaire [ Time Frame: 3 years ]
    1. the medication required to control the IOP
    2. the additional surgery required to control the progression of the PAC

  • The change of the best corrected visual acuity after the laser procedure [ Time Frame: 3 years ]
  • The number of the cornea endothelial cells [ Time Frame: 3 years ]
  • The change in angle width and configuration as measured by ultrasound biomicroscopy (UBM) [ Time Frame: 3 years ]

Estimated Enrollment: 240
Study Start Date: October 2015
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: single LPI
LPI was performed with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. The treatment site was selected in the superior nasal iris or in a crypt, where present. Treatment was initiated with a pulse of 3-5mJ, the power was increased until patency was achieved, the opening of iris >0.1mm. and patency was determined by direct visualization of the posterior chamber.
Device: neodymium:yttrium-aluminum- garnet laser
a neodymium:yttrium-aluminum- garnet laser was used to perform the LPI
Drug: Pilocarpine
30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered
Drug: Proparacaine
30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered
Procedure: LPI
LPI was performed with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered. The treatment site was selected in the superior nasal iris or in a crypt, where present. Treatment was initiated with a pulse of 3-5mJ, the power was increased until patency was achieved, the opening of iris >0.1mm. and patency was determined by direct visualization of the posterior chamber.
Experimental: LPIP plus LPI
LPIP was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. Twenty to 30 spots of 250-300 mW power with 300-500 microns of size and duration of 400-500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. Effective iris contraction was considered as a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain. LPI was performed after LPIP procedure
Device: neodymium:yttrium-aluminum- garnet laser
a neodymium:yttrium-aluminum- garnet laser was used to perform the LPI
Device: frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser
a frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser was used to perform the LPIP
Drug: Pilocarpine
30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered
Procedure: LPIP plus LPI
LPIP was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. Twenty to 30 spots of 250-300 mW power with 300-500 microns of size and duration of 400-500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. Effective iris contraction was considered as a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain. LPI was performed after LPIP procedure.
Drug: Proparacaine
30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of primary angle closure (PAC), with IOP≤30mmHg and PAS≤270°.
  2. PAC with multi-mechanism based on UBM examination (multi-mechanism is defined as primary angle closure is caused by pupil block plus at least one kind of non-pupil block factors like (relative anterior position and thick of the ciliary body, the big volume of the iris, the anterior location of the iris insertion into the ciliary body)or any two or more kinds of combination.
  3. Visual acuity≥ 20/40
  4. Age between 40-75 years old Chinese people

If both eyes of a patient are eligible for the study, the e eye had worse visual acuity will be selected. Only one eye per patient is eligible for the study.

Drug washout:

Eligible patients who are already on anti-glaucoma medications are required to have drug washout before being randomized. Various medications have different washout periods: Prostaglandin analogues 4 weeks, Beta blockers 3 weeks, Adrenergic agonist 2 weeks, Cholinergic agonist 5 days, Carbonic Anhydrase Inhibitors 5 days. Patients whose IOP>30 mm Hg during this washout period will be stopped from further washout and be withdrawn from the study.

Exclusion Criteria:

  1. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
  2. Angle closure due to secondary causes (subluxed lens, neovascular, uveitic, traumatic, post-operative)
  3. Previous incisional intraocular surgery or ocular laser in study eye (LPI or LPIP, cyclodestructive procedure, cataract surgery)
  4. Primary angle closure with glaucomatous neuropathy.
  5. Have cataract in the studying eye and anticipated to have cataract surgery in the coming 3 years; the existing cataract affect visual field examination and fundus examination; the visual acuity <20/40 due to the existing cataract.
  6. Who are using IOP lowing drugs and do not have drug washout
  7. Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
  8. Coexisting other ocular diseases (i.e. cornea abnormal or cornea infection, Iridocorneal endothelial syndrome or anterior segment dysgenesis, nanophthalmos, high myopia (>6.0D), Chronic or recurrent uveitis, ocular cancer, trauma, central retinal vein occlusion, central retinal artery occlusion, retinal detachment)
  9. cornea endothelium counting <1000/mm2
  10. need local or systemic steroid long-term use
  11. Unwilling to discontinue contact lens use after surgery
  12. Who are taking parting in other drug clinical trials
  13. Pregnant or nursing women
  14. Severe systemic disease (i.e. diabetes mellitus, hypertension, the end stage of cardiac disease, nephropathy disease, respiratory disease and cancer.
  15. Allergic to pilocarpine or alcaine
  16. Contraindication to ocular laser diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02613013

Contacts
Contact: xiulan zhang, MD,PhD zhangxl2@mail.sysu.edu.cn

Locations
China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xiulan Zhang, MD,PhD       zhangxl2@mail.sysu.edu.cn   
Principal Investigator: Xiulan Zhang, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
Beijing Tongren Hospital
Wenzhou Medical University
The Second Affiliated Hospital of Harbin Medical University
Huazhong University of Science and Technology
The Third Hospital of HanDan
Third Affiliated Hospital of Third Military Medical University
Central South University
He University
Hebei Provincial Eye Hospital
  More Information

Responsible Party: xiulan zhang, MD,PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02613013     History of Changes
Other Study ID Numbers: 2015019
Study First Received: November 5, 2015
Last Updated: November 17, 2016

Additional relevant MeSH terms:
Glaucoma, Angle-Closure
Glaucoma
Ocular Hypertension
Eye Diseases
Anesthetics
Proxymetacaine
Propoxycaine
Pilocarpine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Miotics
Autonomic Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017