Trials Sponsors Conditions Drugs Pricing

Conditions

Branch Retinal Vein Occlusion Chronic Central Serous Retinopathy Diabetic Macular Edema Macular Telangiectasia

Outcome Measures

Primary Outcomes (1)

Best corrected visual acuity
6 months

Secondary Outcomes (1)

Central macular thickness on OCT
6 months

Study Arms (2)

Topcon Endpoint management

EXPERIMENTAL

Active laser treatment

Procedure: Topcon Endpoint Management

Control

SHAM COMPARATOR

Powerless (sham) laser treatment

Procedure: Topcon Endpoint Management

Interventions

Topcon Endpoint ManagementProcedure

ControlTopcon Endpoint management

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The patient must have macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography.
Thickening of the fovea of at least 300 microns (thickness of the central point in OCT) with a standard deviation of the center point \<10% and signal strength of ≥ 5 OCT ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium) properly identified. Also, the initial OCT must be confirmed by repeated measurements on the same day, with the thickness of the central point being within 10% between measurements. In cases where the OCT imaging program can not properly define the limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of the manual by OCT central point of at least 300 microns, the patient will be considered eligible.

Sponsors & Collaborators

Federal University of Rio Grande do Sul
Otherlead

Study Sites (1)

Instituto de Oftalmologia Lavinsky

Porto Alegre, Rio Grande do Sul, 90440051, Brazil

RECRUITING

Daniel Lavinsky, MD, PhDCONTACT+5551982092999 daniellavinsky@gmail.com

Daniel Lavinsky, MD, PhDPRINCIPAL INVESTIGATOR

Related Publications (2)

Lavinsky D, Sramek C, Wang J, Huie P, Dalal R, Mandel Y, Palanker D. Subvisible retinal laser therapy: titration algorithm and tissue response. Retina. 2014 Jan;34(1):87-97. doi: 10.1097/IAE.0b013e3182993edc.
PMID: 23873164BACKGROUND
Lavinsky D, Silva MOD, Chaves AE, Schneider WFM, Lavinsky F, Palanker D. FUNCTIONAL AND STRUCTURAL EFFECTS OF NONDAMAGING RETINAL LASER THERAPY FOR MACULAR TELANGIECTASIA TYPE 2: A Randomized Sham-Controlled Clinical Trial. Retina. 2021 Mar 1;41(3):487-494. doi: 10.1097/IAE.0000000000002882.
PMID: 33370517DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

Daniel Lavinsky, MD, PhD
Federal University of Rio Grande do Sul
PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Lavinsky, MD, PhD

CONTACT

+555133302444 daniellavinsky@gmail.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: One arm receives laser treatment and second arm received powerless laser treatment as a Sham group.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 4, 2013

Study Start

March 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

You may not qualify if:

Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where scatter photocoagulation is required now, or it likely to be needed over the next 6months (for example, eyes with high risk PDR DRS not properly treated with photocoagulation).
Presence of any abnormality that is likely to confound the assessment of the improvement in visual acuity in eyes with macular edema to resolve or improve as an area of hard exudates involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and / or significant opacification (ie, striations within the diameter of a disc from the center of the fovea), or the presence of chorioretinal atrophy involving the center of the macula.
Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.
Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.
Patients who received panphotocoagulation, YAG laser, or peripheral retinal cryoablation (for retinal tears) or focal or grid photocoagulation within the last 12 weeks or more of treatment with focal or grid laser.
Significant opacities of the optical medium, including cataracts, which may interfere with visual acuity, assessment of toxicity or photography background. Patients will not be included if they have high probability of requiring cataract surgery within the next year.
Any intraocular surgery within 6 months prior to study entry. Prior peeling of epiretinal membrane or inner limiting membrane. Any major surgical procedure within one month of study entry Prior irradiation of the head region of the eye under study. Any previous pharmacological treatment for DME, BRVO, CSR or MacTel (including corticosteroid intravitreal, subconjunctival or subtenon) or at any time during the last 90 days for any other condition.
Important known allergies to sodium fluorescein dye used in angiography. Acute ocular or periocular infection.

Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Topcon Endpoint management

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Topcon Endpoint management

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations