Light and diabetic eye disease

The effect of prevention of Dark Adaptation (DA) on the progress of Diabetic Macular oEdema (DME)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34037927

Enrollment

Registered

2009-11-30

Start date

2009-03-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Diabetic retinopathy Eye Diseases Other disorders of eye and adnexa in diseases classified elsewhere

Interventions

Patients will sleep wearing a device ('light mask') that illuminates one (closed) eyelid. The eye is chosen at random. The other eye acts as control. Each patient will be treated for 6 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults age 18-65 2. No systemic disease apart from diabetes (type I or II) 3. Symmetrical DME which cannot be treated surgically, or does not require immediate intervention

Exclusion criteria

Exclusion criteria: 1. Any other systemic disease or severe diabetic complication 2. Any other eye condition except refractive error of > 5 D 3. History of any psychological disturbance 4. Persons of no fixed abode 5. Sleep apnoea. 6. Inability to tolerate the device, or difficulty in sleeping wearing the device.

Design outcomes

Primary

Measure	Time frame
1. Ocular coherence tomography (OCT) 2. Microperimetry 3. Colour contrast sensitivity 4. Visual acuity 5. Digital fundus photography with quantitative analysis of microaneurysms Investigations are made at baseline, 3 and 6 months	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026