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Trial record 13 of 1347 for:    rural

A Trial of China Laser and Surgery Study Glaucoma in Rural China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02955849
Recruitment Status : Unknown
Verified November 2016 by Congdon Nathan, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Brief Summary:

Aims and Objectives (Quantitative) Aim: To compare the effectiveness of selective laser trabeculoplasty with trabeculoplasty in lowering the intraocular pressure in patients with medically uncontrolled open angle glaucoma in rural China, taking into account the impact of patient acceptance of each type of treatment

Hypothesis: Mean intraocular pressure after treatment with selective laser trabeculoplasty will be lower than with surgery due to higher acceptance rates among patients randomized to receive this treatment and therefore treatment provided at an earlier stage of disease progression.


Condition or disease Intervention/treatment Phase
Glaucoma Device: SLT laser Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The China Laser and Surgery Study : A Mixed Methods Study With an Random Control Trial Comparing Outcomes From Selective Laser Trabeculoplasty Versus Surgical Treatment (Trabeculectomy) for Glaucoma in Rural China .
Study Start Date : September 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: SLT laser group
  1. selective laser trabeculoplasty for 360 degrees the study eye.
  2. Patients having 1 or 2 quadrants of angle with trabecular meshwork not visible will undergo Laser peripheral iridotomy prior to selective laser trabeculoplasty to maximize the amount of angle visible;
  3. Cataract surgery will be offered if indicated and completed within 3 months of selective laser trabeculoplasty , if accepted by the patient.
  4. Patients will be re-examined every 4 months and selective laser trabeculoplasty performed again according to the above protocol if intraocular pressure exceeds the target (25% reduction from the original intraocular pressure or < 21 mmHg, whichever is lower).
Device: SLT laser
Patients will be offered initial SLT laser by doctors

No Intervention: Standard care group
  • Trabeculectomy as usually performed by the operative surgeon in one eye (study eye).
  • Both Mitomycin and releasable sutures are permitted if indicated in the opinion of the surgeon and s/he can perform and/or has access.
  • Simultaneous cataract surgery is permitted if indicated in the opinion of the operating surgeon.
  • Patients will be re-examined every 4 months, and Timolol 0.5% added bid if intraocular pressure exceeds the target (25% reduction from the original intraocular pressure or < 21 mmHg, whichever is lower)
No Intervention: Drug treatment group
Patients not accepting the offered treatment for the study eye within 3 months will receive topical Timolol 0.5% bid at the usual price, with the prescription to be refilled per usual practice at the hospital (usually monthly).



Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 12 months ]
    • intraocular pressure in study eye 12 months after receiving treatment (laser or surgery)
    • the intraocular pressure of patients refusing their allocated intervention will still be recorded at 12 months post-refusal and will be considered in the analysis
    • patients accepting the allocated treatment > 3 months after initial offer of treatment will be considered as having refused and their outcome intraocular pressure will be the last reading prior to treatment


Secondary Outcome Measures :
  1. Visual quality of life [ Time Frame: 12 months ]
    use the scale "NEI-VQ 25" to assess the patient's visual quality of life

  2. Satisfaction score [ Time Frame: 12 months ]
    Using a Surgical Satisfaction Questionnaire previously validated in rural China

  3. Cataract surgery [ Time Frame: 12 months ]
    Cataract surgery performed in conjunction with allocated treatment (Yes/No)

  4. Allocated treatment [ Time Frame: 12 months ]
    use acceptance questionnaire form to calculate surgical receiving rate



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of glaucoma (Cup to disk ratio, or CDR > 0.6 with optic nerve appearance and/or visual field findings consistent with glaucoma in the study eye)
  • angle configuration > 180° of trabecular meshwork visible in the study eye
  • no previous ocular incisional surgery or ocular laser treatment except refractive or cataract surgery in the study eye
  • Best corrected visual acuity > 6/60 metres in both eyes

Exclusion Criteria:

  • Intraocular pressure > 35 in the study eye
  • Cup to disk ratio > 0.9 in the study eye
  • Inability to give informed consent.

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): NCT02955849


Locations
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China, Guangdong
Blindness Preventment and Treatment Department
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Nathan G Congdon, MD,MPH Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications:

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Responsible Party: Congdon Nathan, vice directior, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02955849     History of Changes
Other Study ID Numbers: SLT in rural China
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Congdon Nathan, Sun Yat-sen University:
glaucoma
rural
China
SLT
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases