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

6. maj 2022 opdateret af: Congdon Nathan, Sun Yat-sen University

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Wenhui Zhu, MD
  • Telefonnummer: 8400 86-20-87755766
  • E-mail: dctzwh@139.com

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • Rekruttering
        • Zhongshan Ophthalmic Center
        • Kontakt:
        • Ledende efterforsker:
          • Nathan Congdon, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Early Intervention
pan-retinal photocoagulation laser treatment applied to the study eye within 2-4 weeks.
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.
Andre navne:
  • PRP laser treatment
Aktiv komparator: Standard Care
pan-retinal photocoagulation laser treatment deferred until the onset of any PDR.
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.
Andre navne:
  • PRP laser treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of eyes progressing to any degree of PDR
Tidsramme: 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.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of early versus standard treated eyes with: Loss of >= 10 and of 15 ETDRS letters
Tidsramme: 1 year
1 year
Mean change in best corrected visual acuity from baseline to week 52.
Tidsramme: 1 year
1 year
Proportion of early versus standard treated eyes with: retinal detachment
Tidsramme: 1 year
1 year
Proportion of early versus standard treated eyes with: increase of diabetic macular edema per Optical Coherence Tomography
Tidsramme: 1 year
1 year
Sensitivity & specificity of the diagnosis of any degree of PDR among study ophthalmologists
Tidsramme: 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.)
1 year

Andre resultatmål

Resultatmål
Tidsramme
Comparing the Early versus Standard groups: Proportion of participants show on recommended revisits on time and accept recommended treatments (laser treatment .etc)
Tidsramme: 1 year
1 year
Patient vision-related quality of life (VRQOL); composite and individual domain scores of the NEI VFQ25 questionnaire.
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sun Yat-sen University

Samarbejdspartnere

First Affiliated Hospital, Sun Yat-Sen University
Queen's University, Belfast

Efterforskere

  • Ledende efterforsker: Nathan Congdon, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2016

Primær færdiggørelse (Forventet)

1. oktober 2023

Studieafslutning (Forventet)

1. oktober 2023

Datoer for studieregistrering

Først indsendt

12. oktober 2016

Først indsendt, der opfyldte QC-kriterier

3. november 2016

Først opslået (Skøn)

6. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZOC-PEARL STUDY

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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