Pattern Laser Versus Conventional Laser in Diabetic Retinopathy

NCT ID: NCT03672656

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-01

Study Completion Date

2014-01-25

Brief Summary

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Purpose: To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy.

Methods: The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (SSP) (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method (MSM).

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pattern scanning laser system Pascal

Group Type EXPERIMENTAL

lasercoagulation by Pascal system

Intervention Type DEVICE

pattern scanning laser system Pascal given in a single-session

conventional laser

Group Type ACTIVE_COMPARATOR

conventional laser

Intervention Type DEVICE

conventional laser multiple-session treatment

Interventions

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lasercoagulation by Pascal system

pattern scanning laser system Pascal given in a single-session

Intervention Type DEVICE

conventional laser

conventional laser multiple-session treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diabetic retinopathy

Exclusion Criteria

* No
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Nemcansky J, Stepanov A, Nemcanska S, Masek P, Langrova H, Studnicka J. Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness. PLoS One. 2019 Jul 16;14(7):e0219282. doi: 10.1371/journal.pone.0219282. eCollection 2019.

Reference Type DERIVED
PMID: 31310626 (View on PubMed)

Other Identifiers

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FNO-OCNI-Pascal

Identifier Type: -

Identifier Source: org_study_id

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