With 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.
ID
Bron
Verkorte titel
Aandoening
Diabetic macular edema.
Ondersteuning
Het Oogziekenhuis Rotterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change of microperimetry outcome (dB) at 6 months.
Achtergrond van het onderzoek
Rationale:
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).
Doel van het onderzoek
With 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.
Onderzoeksopzet
3, 6, 9, 12 months.
Onderzoeksproduct en/of interventie
Arm 1: Standard laser photocoagulation treatment;
Arm 2: Navilas™ threshold preset laser pattern;
Arm 3: Navilas™ subthreshold preset laser pattern.
Algemeen / deelnemers
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten.oogziekenhuis.nl
Wetenschappers
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten.oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3040 |
| NTR-old | NTR3188 |
| CCMO | NL37528.078.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35722 |