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Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial

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ClinicalTrials.gov Identifier: NCT02956759
Recruitment Status : Unknown
Verified November 2016 by Congdon Nathan, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Queen's University, Belfast
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
Proportion of eyes progressing to any degree of PDR [ Time Frame: 1 year ]
The diagnosis of PDR will be made by detecting either active new vessels in the optic nerve head or elsewhere in the retina as determined by fundus photography read by a masked investigator or preretinal/vitreous haemorrhage at any time during the 12 month follow-up period.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters [ Time Frame: 1 year ]
  • Mean change in best corrected visual acuity from baseline to week 52. [ Time Frame: 1 year ]
  • Proportion of early versus standard treated eyes with: retinal detachment [ Time Frame: 1 year ]
  • Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography [ Time Frame: 1 year ]
  • Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists [ Time Frame: 1 year ]
    Study ophthalmologists will also ascertain the primary outcome measure (diagnosis of any degree of PDR) on the basis of slit-lamp biomicropscopy fundus examination with a contact lens and indirect ophthalmoscopy. We will compare the sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists with the gold stander (diagnosis provided by graders according to the fundus photos.)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 3, 2016)
  • Comparing the Early versus Standard groups: Proportion of participants show on recommended revisits on time and accept recommended treatments (laser treatment .etc) [ Time Frame: 1 year ]
  • Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire. [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial
Official Title  ICMJE Early Laser Treatment for Diabetic Eye Disease in China: The PEARL Pilot Randomized Trial
Brief Summary

To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in China.

Interview data from some patients and survey data from ophthalmologists in the study hospitals will help determine acceptability of early treatment, and how to overcome barriers to increased use of this option.

Detailed Description China now has the world's largest number of diabetic persons. Population studies show that only 10% of Chinese rural-dwellers with DR receive therapy. The current standard approach to treatment of DR often requires patients to return for multiple examinations over years, before they reach trial-proven criteria for treatment. This long process is ill-suited to support good compliance with care in low-resource settings. Our recent published review suggests that earlier PRP treatment, which could reduce the burden of compliance, may be clinically effective and cost effective, but the current evidence base is insufficient to make a firm recommendation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Retinopathy
Intervention  ICMJE Procedure: Pan-retinal photocoagulation laser treatment
PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.
Other Name: PRP laser treatment
Study Arms  ICMJE
  • Experimental: Early Intervention
    pan-retinal photocoagulation laser treatment applied to the study eye within 2-4 weeks.
    Intervention: Procedure: Pan-retinal photocoagulation laser treatment
  • Active Comparator: Standard Care
    pan-retinal photocoagulation laser treatment deferred until the onset of any PDR.
    Intervention: Procedure: Pan-retinal photocoagulation laser treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults aged >= 18 years with untreated DR at severe or very severe NPDR stage in either one or both eyes, according to the clinical opinion of the investigator.
  • Sufficiently clear ocular media to allow visualization of the retina and retinal photography in either eye.
  • Capable of giving informed consent.

Exclusion Criteria:

  • DR at later stage of retinopathy than severe or very severe (eg, two or more of the 4-2-1 criteria are met) NPDR in either eye, but a patient may be enrolled if one eye has severe or very severe NPDR and the fellow eye has PRP-treated PDR and has been stable after treatment.
  • Clinically significant macular edema in either eye.
  • Dense cataracts or other media opacity preventing visualization of the retina in the eye.
  • History of previous surgical or laser treatment for DR or other retinal conditions in a study eye, including history of anti-VEGF or corticosteroid injection or focal laser for DME within 6 months, or any history of scleral buckle, vitrectomy or other retinal detachment repair.
  • History of other retinal vascular disorders including CRVO, CRAO, BRVO, BRAO in the study eye.
  • Previous cataract or glaucoma surgery is specifically allowed if performed ≥ 6 weeks prior to enrollment.
  • Pregnancy.
  • Severe renal insufficiency treated with hemodialysis treatment, kidney transplant, pancreatic transplant, and intensive insulin therapy initiated within 4 months.
  • Nystagmus, unable to cooperate with laser treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956759
Other Study ID Numbers  ICMJE ZOC-PEARL STUDY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Congdon Nathan, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE
  • First Affiliated Hospital, Sun Yat-Sen University
  • Queen's University, Belfast
Investigators  ICMJE
Principal Investigator: Nathan Congdon, PhD Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP