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
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Pattern scan laser, Proliferative diabetic retinopathy, Pain
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
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
NCT ID
NCT02645383
First Posted
December 19, 2015
Last Updated
December 30, 2015
Sponsor
Kocatepe University
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:
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9538986
Citation
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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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