NCT01759121

Brief Summary

This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2013

Completed
3.2 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

December 18, 2012

Last Update Submit

October 12, 2017

Conditions

Severe Non-proliferative Diabetic Retinopathy

Keywords

severe non-proliferative diabetic retinopathysubthresholdpanretinal photocoagulationPASCALendpoint management

Outcome Measures

Primary Outcomes (2)

  • change of best corrected visual acuity

    best corrected visual acuity

    1 year

  • the probability of vitreous haemorrhage

    1 year

Secondary Outcomes (8)

  • Central Retinal Thickness

    1 year

  • foveal volume of macula

    1 year

  • amount of microaneurysms

    1 year

  • amount of bard exudate

    1 year

  • amount of retinal hemorrhage

    1 year

  • +3 more secondary outcomes

Study Arms (2)

T-PRP

ACTIVE COMPARATOR

532nm-short pulse panretinal photocoagulation with PASCAL function

Radiation: T-PRP

S-PRP

EXPERIMENTAL

532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function

Radiation: S-PRP

Interventions

T-PRPRADIATION

532nm-short pulse panretinal photocoagulation with PASCAL function

Also known as: Traditional-PRP
T-PRP
S-PRPRADIATION

532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function

Also known as: Subthreshold PRP
S-PRP

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of severe non-proliferative diabetic retinopathy
  • Age:45-80 years
  • Best corrected visual acuity(BCVA) ≥20/100,Myopia≤-6 degree(-6D)
  • No photocoagulation (PRP) before this clinical trial and no major ocular surgery (including cataract extraction, or any other intraocular surgery) within 3 months
  • Ability and willingness to provide informed consent

You may not qualify if:

  • Participate in other clinical trials within 3 months
  • Severe refractive media turbidity; Unable to accept laser treatment such as nystagmus, etc
  • Medically or mentally unstable(including cardiovascular disorders, cerebrovascular diseases,liver and kidney disease,hematological disorder and psychosis
  • Conditions that in the opinion of the investigator would interfere trial results or increase risk
  • Conditions that in the opinion of the investigator would preclude participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

  • Li Z, Lu T, Zhou L, Huang C, Zhao H, Liang J, Li C, Cong Q, Lan Y, Jin C. Retinal and Choroidal Alterations in Diabetic Retinopathy Treatment using Subthreshold Panretinal Photocoagulation with Endpoint Management Algorithm: A Secondary Analysis of a Randomized Clinical Trial. Ophthalmol Ther. 2023 Aug;12(4):1867-1880. doi: 10.1007/s40123-023-00713-0. Epub 2023 Apr 30.

    PMID: 37120774DERIVED

  • Zhao H, Zhou L, Lai K, Yu M, Huang C, Xu F, Li C, Lu L, Jin C. Comparison of functional changes of retina after subthreshold and threshold pan-retinal photocoagulation in severe non-proliferative diabetic retinopathy. Lasers Med Sci. 2022 Dec;37(9):3561-3569. doi: 10.1007/s10103-022-03635-8. Epub 2022 Sep 7.

    PMID: 36070046DERIVED

Related Links

Study Officials

  • Chen-jin Jin

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

  • Pei-pei Wu

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-pei Wu

CONTACT

13602457876ree04@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 18, 2012

First Posted

January 2, 2013

Study Start

March 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

CN(1)