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PASCAL Laser Platform Produces Less Pain Responses Compared To Conventional Laser System

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PASCAL laser
Conventional laser
Sponsored by
Kocatepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Pattern scan laser, Proliferative diabetic retinopathy, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients (>18 years) with type 1 or 2 diabetes and bilateral high-risk proliferative diabetic retinopathy (PDR)

Exclusion Criteria:

  • Patients with a history of focal/grid photocoagulation, a history of orbital trauma, orbital infection or surgery, those with corneal or lens opacities, those with vitreous hemorrhage and non-compliant patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    PASCAL group

    Conventional group

    Arm Description

    Patients undergone PASCAL laser photocoagulation

    Patients undergone conventional laser photocoagulation

    Outcomes

    Primary Outcome Measures

    Verbal Score for pain
    Verbal Score for pain was measured as units on the scale 10 minutes after the completion the laser procedure.
    Visual analog score for pain
    Visual Analog Score for pain was measured as units on the scale 10 minutes after the completion the laser procedure.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2015
    Last Updated
    December 30, 2015
    Sponsor
    Kocatepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02645383
    Brief Title
    PASCAL Laser Platform Produces Less Pain Responses Compared To Conventional Laser System
    Official Title
    An Observational Prospective Study of Comparing Pain Responses With Pattern Laser Platform and Conventional Laser System During the Panretinal Photocoagulation in Proliferative Diabetic Retinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kocatepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare the severity of expressed pain scores in patients with PDR who underwent either PASCAL or conventional laser and to assess the association between patient characteristics and severity of pain.
    Detailed Description
    Proliferative diabetic retinopathy (PDR) is a severe complication of diabetes mellitus characterized by new vessel formation in the retina and optic disc. Tight glycemic control and laser treatment in the early phases of the disease may slow the progression of PDR. Panretinal photocoagulation (PRP) is a laser-based treatment modality that destroys the outer retina layers and thereby improves the oxygen supply of the inner retina. During the following years, sequential improvements took place, including introduction of yellow, green, and diode lasers with various advantages of each wavelength. In 2006, a novel semi-automatic and multi-shot photocoagulator called as PASCAL (Pattern scan laser, Opti-Medica Corp., Santa Clara, California, USA) was introduced with a reduction in pulse duration of each laser spot from typical 100 ms down to 10-30 millisecond. Compared with the conventional laser, shorter pulses have been shown to significantly reduce the risk of damage to the adjacent retinal tissues. Almost all patients experience pain during PRP. While some patients may tolerate the pain, the majority does not. One study reported that 64.1% of patients did not complete treatment due to pain and therefore had an increased risk of vision loss. To improve patient compliance, several anesthetic and analgesic techniques such as peribulbar anesthesia, oral anesthesia and topical eye drops have been used. The patient comfort, and thus compliance, may be improved by using the shorter exposure burns, avoiding red or infrared wavelengths with deeper penetration, and by decreasing overall treatment time. The aim of the current study was to compare the severity of expressed pain scores in patients with PDR who underwent either PASCAL or conventional laser. As a method of this study, both eyes were treated within the same session and while one eye was treated with PASCAL laser, the other was treated with conventional laser (ELLEX Integre, Adailade, Australia) with 30 minutes resting intervals. To avoid a bias about orientation or becoming accustomed to laser procedure, PASCAL laser was performed in the first eyes in half of the patients (14 patients) and conventional laser was performed in the first eyes in the other half of the patients randomly. While the spot size used to obtain a white-grayish spot on the retina was 200-400 µm in both PASCAL and conventional laser, the pulse duration was 100 ms with conventional laser and 30ms with PASCAL laser. In order to accurately and reliable compare the grade of pain between each procedures, the retinal areas and total number of spots were standardized. Similar numbers of laser spots were created by two laser systems in same retinal quadrants in both eyes. Ten minutes after the procedure ended the severity of pain was assessed using a verbal rating scale and a visual analog scale (VAS). In the verbal scale the patient rates the pain on a Likert scale verbally, e.g. "none", "mild pain", "moderate pain", "severe pain" or "very severe pain" in five grading system (0-4) and in the VAS they specify the severity of pain by indicating a position along a continuous line from 0 to 10. Using these scores, relationship between severity of pain and patient characteristics including history of prior PRP treatment (experience), gender and duration of diabetes mellitus were assessed. Patients were assigned either in the experienced or non-experienced groups depending on history of prior PRP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Retinopathy
    Keywords
    Pattern scan laser, Proliferative diabetic retinopathy, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PASCAL group
    Arm Type
    Active Comparator
    Arm Description
    Patients undergone PASCAL laser photocoagulation
    Arm Title
    Conventional group
    Arm Type
    Active Comparator
    Arm Description
    Patients undergone conventional laser photocoagulation
    Intervention Type
    Device
    Intervention Name(s)
    PASCAL laser
    Intervention Description
    A novel semi-automatic and multi-shot photocoagulator called as PASCAL (Pattern scan laser, Opti-Medica Corp., Santa Clara, California, USA) was introduced with a reduction in pulse duration of each laser spot from typical 100 ms down to 10-30 millisecond. Compared with the conventional laser, shorter pulses have been shown to significantly reduce the risk of damage to the adjacent retinal tissues. One eye was treated with PASCAL laser, the other was treated with conventional laser with 30 minutes resting intervals. To avoid a bias about orientation or becoming accustomed to laser procedure, PASCAL laser was performed in the first eyes in half of the patients (14 patients) randomly.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional laser
    Intervention Description
    Maintaining of good glycemic regulation and performing panretinal laser photocoagulation (PRP) with conventional laser device (ELLEX Integre, Adailade, Australia) when it is indicated are evidence based effective methods for proliferative diabetic retinopathy.One eye was treated with conventional laser, the other was treated with PASCAL laser with 30 minutes resting intervals. To avoid a bias about orientation or becoming accustomed to laser procedure, conventional laser was performed in the first eyes in half of the patients (14 patients) randomly.
    Primary Outcome Measure Information:
    Title
    Verbal Score for pain
    Description
    Verbal Score for pain was measured as units on the scale 10 minutes after the completion the laser procedure.
    Time Frame
    3 months
    Title
    Visual analog score for pain
    Description
    Visual Analog Score for pain was measured as units on the scale 10 minutes after the completion the laser procedure.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients (>18 years) with type 1 or 2 diabetes and bilateral high-risk proliferative diabetic retinopathy (PDR) Exclusion Criteria: Patients with a history of focal/grid photocoagulation, a history of orbital trauma, orbital infection or surgery, those with corneal or lens opacities, those with vitreous hemorrhage and non-compliant patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Umit U Inan, M.D
    Organizational Affiliation
    Kocatepe University Medical School Department of Ophthalmology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9538986
    Citation
    Aiello LP, Gardner TW, King GL, Blankenship G, Cavallerano JD, Ferris FL 3rd, Klein R. Diabetic retinopathy. Diabetes Care. 1998 Jan;21(1):143-56. doi: 10.2337/diacare.21.1.143. No abstract available.
    Results Reference
    result
    PubMed Identifier
    22788579
    Citation
    Feman SS, Chen J, Burroughs TE. Change in diabetic panretinal photocoagulation incidence. Ophthalmic Surg Lasers Imaging. 2012 Jul 1;43(4):270-4. doi: 10.3928/15428877-20120618-02.
    Results Reference
    result
    PubMed Identifier
    18195222
    Citation
    Jain A, Blumenkranz MS, Paulus Y, Wiltberger MW, Andersen DE, Huie P, Palanker D. Effect of pulse duration on size and character of the lesion in retinal photocoagulation. Arch Ophthalmol. 2008 Jan;126(1):78-85. doi: 10.1001/archophthalmol.2007.29.
    Results Reference
    result
    PubMed Identifier
    16508446
    Citation
    Blumenkranz MS, Yellachich D, Andersen DE, Wiltberger MW, Mordaunt D, Marcellino GR, Palanker D. Semiautomated patterned scanning laser for retinal photocoagulation. Retina. 2006 Mar;26(3):370-6. doi: 10.1097/00006982-200603000-00024. No abstract available.
    Results Reference
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    PubMed Identifier
    19376588
    Citation
    Zakrzewski PA, O'Donnell HL, Lam WC. Oral versus topical diclofenac for pain prevention during panretinal photocoagulation. Ophthalmology. 2009 Jun;116(6):1168-74. doi: 10.1016/j.ophtha.2009.01.022. Epub 2009 Apr 19.
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    PubMed Identifier
    16021194
    Citation
    Wu WC, Hsu KH, Chen TL, Hwang YS, Lin KK, Li LM, Shih CP, Lai CC. Interventions for relieving pain associated with panretinal photocoagulation: a prospective randomized trial. Eye (Lond). 2006 Jun;20(6):712-9. doi: 10.1038/sj.eye.6701989. Epub 2005 Jul 8.
    Results Reference
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    PubMed Identifier
    20608612
    Citation
    Alvarez-Verduzco O, Garcia-Aguirre G, Lopez-Ramos Mde L, Vera-Rodriguez S, Guerrero-Naranjo JL, Morales-Canton V. Reduction of fluence to decrease pain during panretinal photocoagulation in diabetic patients. Ophthalmic Surg Lasers Imaging. 2010 Jul-Aug;41(4):432-6. doi: 10.3928/15428877-20100525-02. Epub 2010 May 28.
    Results Reference
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    PubMed Identifier
    15671304
    Citation
    Schuele G, Rumohr M, Huettmann G, Brinkmann R. RPE damage thresholds and mechanisms for laser exposure in the microsecond-to-millisecond time regimen. Invest Ophthalmol Vis Sci. 2005 Feb;46(2):714-9. doi: 10.1167/iovs.04-0136.
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    PubMed Identifier
    10758220
    Citation
    Mainster MA. Decreasing retinal photocoagulation damage: principles and techniques. Semin Ophthalmol. 1999 Dec;14(4):200-9. doi: 10.3109/08820539909069538.
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    Citation
    Al-Hussainy S, Dodson PM, Gibson JM. Pain response and follow-up of patients undergoing panretinal laser photocoagulation with reduced exposure times. Eye (Lond). 2008 Jan;22(1):96-9. doi: 10.1038/sj.eye.6703026. Epub 2007 Nov 23.
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    Citation
    Nagpal M, Marlecha S, Nagpal K. Comparison of laser photocoagulation for diabetic retinopathy using 532-nm standard laser versus multispot pattern scan laser. Retina. 2010 Mar;30(3):452-8. doi: 10.1097/IAE.0b013e3181c70127.
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    Citation
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    PASCAL Laser Platform Produces Less Pain Responses Compared To Conventional Laser System

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