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

NCT02645383 | Completed

• 1 other identifier: 0112S299
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy

Keywords

Pattern scan laser; Proliferative diabetic retinopathy; Pain

Outcome Measures

Primary Outcomes (2)

• Verbal Score for pain

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

  3 months

• 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.

  3 months

Study Arms (2)

PASCAL group

ACTIVE COMPARATOR

Patients undergone PASCAL laser photocoagulation

Device: PASCAL laser

Conventional group

ACTIVE COMPARATOR

Patients undergone conventional laser photocoagulation

Device: Conventional laser

Interventions

PASCAL laser DEVICE

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.

PASCAL group

Conventional laser DEVICE

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.

Conventional group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocatepe University: lead

Related Publications (12)

• 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.

  PMID: 9538986 RESULT

• 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.

  PMID: 22788579 RESULT

• 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.

  PMID: 18195222 RESULT

• 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.

  PMID: 16508446 RESULT

• 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.

  PMID: 19376588 RESULT

• 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.

  PMID: 16021194 RESULT

• 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.

  PMID: 20608612 RESULT

• 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.

  PMID: 15671304 RESULT

• Mainster MA. Decreasing retinal photocoagulation damage: principles and techniques. Semin Ophthalmol. 1999 Dec;14(4):200-9. doi: 10.3109/08820539909069538.

  PMID: 10758220 RESULT

• 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.

  PMID: 18034195 RESULT

• 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.

  PMID: 20216293 RESULT

• Muqit MM, Marcellino GR, Gray JC, McLauchlan R, Henson DB, Young LB, Patton N, Charles SJ, Turner GS, Stanga PE. Pain responses of Pascal 20 ms multi-spot and 100 ms single-spot panretinal photocoagulation: Manchester Pascal Study, MAPASS report 2. Br J Ophthalmol. 2010 Nov;94(11):1493-8. doi: 10.1136/bjo.2009.176677. Epub 2010 Jun 16.

  PMID: 20558423 RESULT

MeSH Terms

Conditions

Diabetic Retinopathy; Pain

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Umit U Inan, M.D

  Kocatepe University Medical School Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: January 1, 2016
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 1, 2016

Record last verified: 2015-12