No registrations found.
ID
Source
Brief title
Health condition
Diabetic macular edema.
Sponsors and support
Het Oogziekenhuis Rotterdam
Intervention
Outcome measures
Primary outcome
Change of microperimetry outcome (dB) at 6 months.
Secondary outcome
1. 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.
Background summary
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).
Study objective
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.
Study design
3, 6, 9, 12 months.
Intervention
Arm 1: Standard laser photocoagulation treatment;
Arm 2: Navilas™ threshold preset laser pattern;
Arm 3: Navilas™ subthreshold preset laser pattern.
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten.oogziekenhuis.nl
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten.oogziekenhuis.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3040 |
| NTR-old | NTR3188 |
| CCMO | NL37528.078.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35722 |