NCT02621580

Brief Summary

Laser therapy is an established method to stabilize and control proliferative diabetic eye disease. Questions on the long-term effect on the retina from these treatments remain to be answered. The purpose of the study was to evaluate changes in the retina following panretinal photocoagulation (PRP) over time, using structural and functional diagnostic tests.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

4.9 years

First QC Date

November 27, 2015

Last Update Submit

April 30, 2019

Conditions

Diabetic Retinopathy

Keywords

Panretinal Photocoagulation

Outcome Measures

Primary Outcomes (1)

  • The rate of structural and functional changes to the retinal thickness following PASCAL PRP in severe PDR patients, assessed by optical coherence tomography.

    2 years

Study Arms (2)

Control

NO INTERVENTION

Patients with type 1 or type 2 diabetes mellitus (according to ADA or WHO guidelines) that have severe preproliferative or proliferative diabetic retinopathy and do not require laser or anti-VEGF treatment in at least one eye.

Treatment: Pan-Retinal Photocoagulation

EXPERIMENTAL

Patients with type 1 or type 2 diabetes mellitus (according to ADA or WHO guidelines) that have severe preproliferative or proliferative diabetic retinopathy and require PRP laser in at least one eye.

Device: Pan-Retinal Photocoagulation

Interventions

Pan-Retinal PhotocoagulationDEVICE

Diabetic retinopathy does not usually impair sight until the development of long-term complications, including proliferative retinopathy, a condition in which abnormal new blood vessels may rupture and bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal photocoagulation is usually recommended. During this procedure, a special laser is used to make tiny burns that seal the retina and stop vessels from growing and leaking. Hundreds of tiny spots of laser are placed in the retina to reduce the risk of vitreous haemorrhage and retinal detachment.

Treatment: Pan-Retinal Photocoagulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient's greater than 18 years of age who have signed an informed consent.
  • Patients with type 1 or type 2 diabetes mellitus (according to ADA or WHO guidelines) that have severe preproliferative or proliferative diabetic retinopathy and require PRP surgery in at least one eye.
  • Adequate pupil dilation and clear media to perform laser photocoagulation, HRT, OCT and visual field testing.

You may not qualify if:

  • Advanced lens opacity (Lens opacity that excludes the ability to capture data)
  • Prior PRP within the past year
  • Focal laser within one year of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Klein R. Prevention of visual loss from diabetic retinopathy. Surv Ophthalmol. 2002 Dec;47 Suppl 2:S246-52. doi: 10.1016/s0039-6257(02)00388-0.

    PMID: 12507626BACKGROUND

  • Lim MC, Tanimoto SA, Furlani BA, Lum B, Pinto LM, Eliason D, Prata TS, Brandt JD, Morse LS, Park SS, Melo LA Jr. Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance. Arch Ophthalmol. 2009 Jul;127(7):857-62. doi: 10.1001/archophthalmol.2009.135.

    PMID: 19597104BACKGROUND

  • Kim HY, Cho HK. Peripapillary retinal nerve fiber layer thickness change after panretinal photocoagulation in patients with diabetic retinopathy. Korean J Ophthalmol. 2009 Mar;23(1):23-6. doi: 10.3341/kjo.2009.23.1.23. Epub 2009 Mar 9.

    PMID: 19337475BACKGROUND

  • Muqit MM, Marcellino GR, Henson DB, Fenerty CH, Stanga PE. Randomized clinical trial to evaluate the effects of Pascal panretinal photocoagulation on macular nerve fiber layer: Manchester Pascal Study report 3. Retina. 2011 Sep;31(8):1699-707. doi: 10.1097/IAE.0b013e318207d188.

    PMID: 21478808BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Cindy Hutnik, MD, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 3, 2015

Study Start

September 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 2, 2019

Record last verified: 2019-04