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.

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. - NAVILAS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35722

Enrollment

Registered

2011-11-29

Start date

2012-03-15

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic macular edema

Interventions

Arm 1: Standard laser photocoagulation treatment. Arm 2: Navilas* threshold preset laser pattern. Arm 3: Navilas* subthreshold preset laser pattern.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Informed consent. Age 30 years or older. Recently diagnosed DME (

Exclusion criteria

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 (

Design outcomes

Primary

Measure	Time frame
Change of microperimetry outcome (dB) at 6 months.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)