A Comparison of Standard Laser With Micropulse Laser for the Treatment of Diabetic Macular Oedema.

NCT03690050 | Completed DMC

• 3 other identifiers: 16028NL-AS2016-003804-29ISRCTN17742985
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 14

Brief Summary

DIAMONDS is a Randomised Controlled Clinical Trial that is being carried out in the UK to determine the clinical effectiveness and cost-effectiveness of micropulse laser, compared with standard laser, for the treatment of diabetic macular oedema.

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular oedema; Diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• Mean change in BCdVA in the study eye at 24 months

  BCdVA in the study eye is assessed by a BCdVA test (using ETDRS visual acuity charts at 4 meters) at baseline and months 4,8,12,16,20 and 24.

  4, 8, 12, 16, 20 and 24 months

Secondary Outcomes (11)

• Mean change in binocular BCdVA from baseline to month 24

  12 and 24 months

• Mean change in central subfield retinal thickness in the study eye

  24 months

• Mean change in the mean deviation (MD) of the Humphrey 10-2 visual field in the study eye from baseline to month 24

  12 and 24 Months

• Change in the percentage (%) of people meeting driving standards from baseline to month 24

  24 months

• Mean change in EQ-5D 5L from baseline to month 24.

  24 months

Study Arms (2)

Diode Subthreshold Micropulse Laser

EXPERIMENTAL

DSML is a relatively new laser technology aimed at minimising damage ("tissue-sparing") to choroid and retina but maintaining treatment efficacy by its selective effect on the retinal pigment epithelium (RPE). It is performed using laser that, instead of delivering a continuous-wave laser beam, as the standard laser, it provides very small, repetitive, low energy pulses of laser separated by a brief rest period. This rest period allows the tissue to cool down between laser pulses avoiding the increased tissue heat that would be produced by continuous laser and allowing the use of lower laser energy power to achieve an effect. The reduced heat produced in the tissue and the reduced energy power required for the treatment may reduce side effects.

Procedure: Diode 577 nm subthreshold micropulse laser

Standard threshold laser (532 nm laser)

ACTIVE COMPARATOR

Green-yellow argon laser photocoagulation at threshold levels has been used for many years as the standard laser for the treatment of many retinal disorders including DMO. The ETDRS demonstrated the efficacy of laser in preventing visual loss in patients with DMO.

Procedure: Standard threshold laser (532 nm laser)

Interventions

Diode 577 nm subthreshold micropulse laser PROCEDURE

On the day the laser procedure is going to be performed, participants will be randomised 1:1 to receive DSML or standard laser using an automated randomisation system. The DSML surgery will be performed by an Ophthamologist

Diode Subthreshold Micropulse Laser

Standard threshold laser (532 nm laser) PROCEDURE

On the day the laser procedure is going to be performed, participants will be randomised 1:1 to receive DSML or standard laser using an automated randomisation system. The standard laser surgery will be performed by an Ophthamologist

Standard threshold laser (532 nm laser)

Eligibility Criteria

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

You may qualify if:

• Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:
• Central retinal subfield thickness of \> 300 but \< 400 microns as determined by SD-OCT due to diabetic macular oedema OR
• Central retinal subfield thickness of \< 300 microns provided that intraretinal and/or subretinal fluid is present in the central subfield (central 1 mm) related to diabetic macular oedema AND
• Visual acuity of \> 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent \> 20/320)
• Amenable to laser treatment, as judged by the treating ophthalmologist
• Over 18 years of age

You may not qualify if:

• Eyes of patients will not be included in the study if:
• The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others
• The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist
• The eye has DMO and central subfield retinal thickness (CST) of \> 400 microns. Doc No: TM09-LB01 Protocol Version 3.0 Final\_ 09/01/17 Page 16 of 34
• The eye has activeA proliferative diabetic retinopathy (PDR) requiring treatment.
• The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.
• The eye has received macular laser treatment within the previous 12 months.
• The eye has received intravitreal injection of steroids.
• The eye has received cataract surgery within the previous six weeks
• The eye has received panretinal photocoagulation within the previous 3 months The patient is
• Patients on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study
• The patient has chronic renal failure requiring dialysis or kidney transplant
• The patient has any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study)
• The patient has very poor glycemic control and started intensive therapy within the previous 3 months
• The patient will use an investigational drug during the study

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Northern Ireland Clinical Trials Unit: collaborator

Study Sites (14)

Belfast Health & Social Care Trust

Belfast, United Kingdom

Location

Bradford Royal Infirmary

Bradford, United Kingdom

Location

Bristol Eye Hospital

Bristol, United Kingdom

Location

Frimley Park Hospital

Frimley, United Kingdom

Location

Hull and East Yorkshire Hospital

Hull, United Kingdom

Location

Hinchingbrooke Hospital

Huntingdon, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Moorefields Eye Hospital

London, United Kingdom

Location

Manchester Eye Hospital

Manchester, United Kingdom

Location

James Cook University Hospital South Tees

Middlesbrough, United Kingdom

Location

Newcastle Eye Hospital

Newcastle, United Kingdom

Location

Oxford John Radcliffe Hospital

Oxford, United Kingdom

Location

Sheffield Eye Hospital

Sheffield, United Kingdom

Location

City Hopsitals Sunderland

Sunderland, United Kingdom

Location

Related Publications (12)

• Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.

  PMID: 2866759 BACKGROUND

• [2] NICE guidance. Ranibizumab for treating diabetic macular oedema. TA 237 (STA), superseded by TA 274 (rapid review). ERG Reports

  BACKGROUND

• Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.

  PMID: 21345996 BACKGROUND

• Vujosevic S, Bottega E, Casciano M, Pilotto E, Convento E, Midena E. Microperimetry and fundus autofluorescence in diabetic macular edema: subthreshold micropulse diode laser versus modified early treatment diabetic retinopathy study laser photocoagulation. Retina. 2010 Jun;30(6):908-16. doi: 10.1097/IAE.0b013e3181c96986.

  PMID: 20168272 BACKGROUND

• Kumar V, Ghosh B, Mehta DK, Goel N. Functional outcome of subthreshold versus threshold diode laser photocoagulation in diabetic macular oedema. Eye (Lond). 2010 Sep;24(9):1459-65. doi: 10.1038/eye.2010.53. Epub 2010 Apr 30.

  PMID: 20431612 BACKGROUND

• Figueira J, Khan J, Nunes S, Sivaprasad S, Rosa A, de Abreu JF, Cunha-Vaz JG, Chong NV. Prospective randomised controlled trial comparing sub-threshold micropulse diode laser photocoagulation and conventional green laser for clinically significant diabetic macular oedema. Br J Ophthalmol. 2009 Oct;93(10):1341-4. doi: 10.1136/bjo.2008.146712. Epub 2008 Dec 3.

  PMID: 19054831 BACKGROUND

• Laursen ML, Moeller F, Sander B, Sjoelie AK. Subthreshold micropulse diode laser treatment in diabetic macular oedema. Br J Ophthalmol. 2004 Sep;88(9):1173-9. doi: 10.1136/bjo.2003.040949.

  PMID: 15317711 BACKGROUND

• Sivaprasad S, Dorin G. Subthreshold diode laser micropulse photocoagulation for the treatment of diabetic macular edema. Expert Rev Med Devices. 2012 Mar;9(2):189-97. doi: 10.1586/erd.12.1.

  PMID: 22404779 BACKGROUND

• Minassian DC, Owens DR, Reidy A. Prevalence of diabetic macular oedema and related health and social care resource use in England. Br J Ophthalmol. 2012 Mar;96(3):345-9. doi: 10.1136/bjo.2011.204040. Epub 2011 May 20.

  PMID: 21602478 BACKGROUND

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  PMID: 24141714 BACKGROUND

• Mistry H, Maredza M, Campbell C, Lois N; DIAMONDS study group. Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of <400micro: a cost-effectiveness analysis from the DIAMONDS trial. BMJ Open. 2023 Oct 18;13(10):e067684. doi: 10.1136/bmjopen-2022-067684.

  PMID: 37852765 DERIVED

• Lois N, Campbell C, Waugh N, Azuara-Blanco A, Maredza M, Mistry H, McAuley D, Acharya N, Aslam TM, Bailey C, Chong V, Downey L, Eleftheriadis H, Fatum S, George S, Ghanchi F, Groppe M, Hamilton R, Menon G, Saad A, Sivaprasad S, Shiew M, Steel DH, Talks JS, Doherty P, McDowell C, Clarke M. Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT. Health Technol Assess. 2022 Dec;26(50):1-86. doi: 10.3310/SZKI2484.

  PMID: 36541393 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Lasers

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Noemi Lois, MD, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Ophthalmologists undertaking laser treatments for DMO at each of the participating centres will also deliver the treatment for the trial. Although, for obvious reasons, ophthalmologists delivering the treatment will not be masked with regards to the laser used, every effort will be made to ensure that participants and outcome assessors (e.g. optometrists measuring visual function, photographers/technicians/nurses obtaining OCT images and ophthalmic technicians obtaining visual fields) will be masked to the allocated treatment. Patients will not be informed before, during, and after the laser treatment about which technology of laser was used for their treatment. Similarly, the investigators obtaining outcome measures will only have access to the CRF booklet (but not to the notes of the patients) which will contain no information with regards to the type of laser the patient had been allocated or received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: October 1, 2018
• Study Start: November 1, 2014
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (14)