To study the impact of laser photocoagulation on the parafoveal visual field in a previously untreated population of patients with DME.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change of microperimetry outcome (dB) at 6 months.
Secondary outcome
Change of microperimetry outcome (dB) at 3, 9 and 12 months.
Change of BCVA (ETDRS), CFT (OCT), autofluorescence (objective macular damage)
at 3, 6, 9, 12 months.
Change of total area of laser burns or retinal pigment epithelium atrophy over
time.
Background summary
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.
Study 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.
Intervention
Arm 1: Standard laser photocoagulation treatment.
Arm 2: Navilas* threshold preset laser pattern.
Arm 3: Navilas* subthreshold preset laser pattern.
Study burden and risks
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).
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Informed consent.
Age 30 years or older.
Recently diagnosed DME (< 3 months).
Diabetes mellitus (i.e. at least 1 year of treatment, and a HbA1c < 10 %).
Able to cooperate with assessments of visual acuity, retinal imaging and microperimetry.
Exclusion criteria
Other ocular condition affecting macular function or obscuring ocular media, thereby influencing visual acuity and/or central visual sensitivity.
Previous panretinal laser.
Intraocular injections or surgery (< 3 months prior to inclusion).
Planned laser, intravitreal injections or surgery (phaco/vitrectomy) within 12 months after inclusion.
Fluorescein allergy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37528.078.11 |
| OMON | NL-OMON22871 |