Morphological and Functional Retinal Changes Following Retinal Photocoagulation

NCT00682240 | Completed Phase 4

• 1 other identifier: Pascal Study
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Imaging of retinal morphological changes with time secondary to laser treatment as assessed with high definition optical coherence tomography (OCT). Furthermore changes in retinal function as an effect of treatment will be documented by visual acuity testing using ETDRS charts and microperimetry. The change in vascular leakage will be assessed by performing fluorescein angiography, flare counts will be performed monthly.

Conditions

Proliferative Diabetic Retinopathy; Macular Edema

Keywords

retinal morphology; laser treatment; pascal laser; HD-OCT

Outcome Measures

Primary Outcomes (1)

• Retinal morphological changes with time secondary to laser treatment as assessed with optical coherence tomography (OCT).

  2007-2014

Secondary Outcomes (1)

• changes in retinal function as an effect of treatment, documented by visual acuity testing and microperimetry. The change in vascular leakage will be assessed by performing fluorescein angiography, flare counts will be performed monthly.

  2007-2009

Study Arms (4)

group 3

ACTIVE COMPARATOR

Group 3: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation. Intervention: All patients will receive a multi-session panretinal laser treatment according to the conventional protocol, using a conventional laser system.

Procedure: laser treatment with conventional laser system

group 2

ACTIVE COMPARATOR

Group 2: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation randomized into group 2. Intervention: This group will receive multi-session panretinal laser treatment. The treatment will be performed using Pascal laser system.

Procedure: laser treatment with PASCAL®

group 1

ACTIVE COMPARATOR

Group 1: 20 patients with proliferative retinopathy secondary to diabetes mellitus or venous occlusion) with need for panretinal photocoagulation randomized into group1. Intervention: One group will receive a single-session panretinal laser treatment, performed using Pascal laser system.

Procedure: laser treatment with PASCAL®

group 4

ACTIVE COMPARATOR

Group 4: 20 patients with persistent central or para-central diabetic macular edema receiving focal or grid laser treatment. As the treatment will be performed according to the conventional protocol (single spot), only the Pascal laser system will be used. Intervention: focal or grid laser treatment

Procedure: laser treatment with PASCAL®

Interventions

laser treatment with PASCAL® PROCEDURE

panretinal laser treatment - single-session

Also known as: PASCAL® (Pattern Scan Laser, OptiMedica ® Corporation)

group 1

laser treatment with conventional laser system PROCEDURE

panretinal laser treatment - multi-session according to the conventional protocol, using a conventional laser system

group 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age 18 years
• Patients with either retinopathy/maculopathy secondary to diabetes mellitus type I or II with medical indication for segmental or panretinal laser coagulation or with necessity for completion of previous incomplete laser photocoagulation.
• Patients with proliferative diabetic retinopathy requiring panretinal laser treatment (Group 1, 2 and 3)
• Patients with macular edema requiring central focal or grid laser treatment (Group 4).

You may not qualify if:

• A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Dept. of Opthalmology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• Deak GG, Bolz M, Prager S, Ritter M, Kriechbaum K, Scholda C, Schmidt-Erfurth U; Diabetic Retinopathy Research Group Vienna. Photoreceptor layer regeneration is detectable in the human retina imaged by SD-OCT after laser treatment using subthreshold laser power. Invest Ophthalmol Vis Sci. 2012 Oct 9;53(11):7019-25. doi: 10.1167/iovs.12-10196. Print 2012 Oct.

  PMID: 22956609 DERIVED

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Ursula Schmidt-Erfurth, MD

  Medial University of Vienna, Dept. of Ophthalmology

  STUDY CHAIR

• Katharina Kriechbaum, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Matthias Bolz, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Sonja Prager, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.Dr.

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: October 1, 2007
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

AU (1)