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Navilas™ laser versus classic frequency doubled Nd-YAG (532 nm) laser therapy for diabetic macular edema. A randomized study analyzing the effect on central visual function.


- candidate number10663
- NTR NumberNTR3188
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-dec-2011
- Secondary IDsNL37528.078.11 / OZR-2011-07; CCMO / Oogziekenhuis Rotterdam
- Public TitleNavilas™ laser versus classic frequency doubled Nd-YAG (532 nm) laser therapy for diabetic macular edema. A randomized study analyzing the effect on central visual function.
- Scientific TitleNavilas™ laser versus classic frequency doubled Nd-YAG (532 nm) laser therapy for diabetic macular edema. A randomized study analyzing the effect on central visual function.
- ACRONYMNAVILAS
- hypothesisWith an image-guided retina laser (Navilas™) it is possible to accurately execute the intended treatment without causing unnecessary retinal damage while further visual loss is prevented.
- Healt Condition(s) or Problem(s) studiedDiabetic macular edema
- Inclusion criteria1. Informed consent;
2. Age 30 years or older;
3. Recently diagnosed DME (< 3 months);
4. Diabetes mellitus (i.e. at least 1 year of treatment, and a HbA1c < 10 %);
5. Able to cooperate with assessments of visual acuity, retinal imaging and microperimetry.
- Exclusion criteria1. Other ocular condition affecting macular function or obscuring ocular media, thereby influencing visual acuity and/or central visual sensitivity;
2. Previous panretinal laser;
3. Intraocular injections or surgery (< 3 months prior to inclusion);
4. Planned laser (PRP), intravitreal injections or surgery (phaco/vitrectomy) within 12 months after inclusion;
5. Fluorescein allergy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2011
- planned closingdate30-nov-2013
- Target number of participants99
- InterventionsArm 1: Standard laser photocoagulation treatment;
Arm 2: Navilas™ threshold preset laser pattern;
Arm 3: Navilas™ subthreshold preset laser pattern.
- Primary outcomeChange of microperimetry outcome (dB) at 6 months.
- Secondary outcome1. Change of microperimetry outcome (dB) at 3, 9 and 12 months;
2. Change of BCVA (ETDRS), CFT (OCT), autofluorescence (objective macular damage) at 3, 6, 9, 12 months;
3. Change of total area of laser burns or retinal pigment epithelium atrophy over time.
- Timepoints3, 6, 9, 12 months.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES T. Missotten
- CONTACT for SCIENTIFIC QUERIES T. Missotten
- Sponsor/Initiator The Rotterdam Eye Hospital
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Oogziekenhuis (SWOO)
- PublicationsN/A
- Brief summaryRationale:
Diabetic macular edema (DME), the incidence of which is expected to increase to 12,500 new patients annually in the Netherlands in 2025, often results in severe visual acuity loss. Visual loss can be significantly reduced by grid laser photocoagulation. With an image-guided retina laser (Navilas™) it is possible to accurately execute the intended treatment without causing unnecessary retinal damage. Thus visual loss may be further prevented.

Objective:
To study the impact of laser photocoagulation on the parafoveal visual field in a previously untreated population of patients with DME.

Study design:
Prospective, randomized, double-masked, 3-arms, comparative study.

Study population:
Patients with recently diagnosed DME without prior treatment.

Intervention:
Arm 1: Standard laser photocoagulation treatment;
Arm 2: Navilas™ threshold preset laser pattern;
Arm 3: Navilas™ subthreshold preset laser pattern.

Main study parameters/endpoints:
Change of microperimetry outcome (dB) at 6 months.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Treatment in all groups is expected to be equally effective with respect to visual acuity and central foveal thickness. Group 3 may benefit from subthreshold laser because less damage is caused. Burden is considered to be moderate to low. All study related measurements will take place during regular control visits. Microperimetry requires the subject's concentrated attention for about half an hour and may be somewhat tiresome. Extra study-related time amounts to approximately 5 hours (1 hour per visit).
- Main changes (audit trail)
- RECORD9-dec-2011 - 27-jan-2016


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