Clinical trial NCT02457884: Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema
Official title: Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema (DMO)- Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Oedema
Parafoveal Scotoma
Keywords: Diabetic macular oedema
Perceptual learning
Chinese
Hong Kong
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2015-05-29
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity finally. However, some patients still have difficulties in reading even after proper treatment.

In this project, the investigators aimed to explore the effectiveness of different training paradigms in improving reading performance in patients with DMO.

Detailed description: Patients with diabetic macular oedema (DMO), after receiving laser photocoagulation, achieved good outcomes in distance acuity. However, some patients, particularly those developing parafoveal scotoma, still had difficulty in reading. Inability to read or reading very slowly leads to the potential loss of job, as well as the enjoyment of reading for leisure.

In this study, the investigators aimed to investigate the effectiveness of reading rehabilitation using perceptual learning paradigms in enhancing reading performance in patients with reading difficulties due to DMO. Also, the fundamental mechanisms explaining the reading problems in patients with DMO reading Chinese will be examined.

The investigators hypothesize that the perceptual training would show an improvement in reading. The investigators' primary hypothesis is that temporal visual processing speed and spatial visual span will be improved after perceptual training. The investigators' secondary hypothesis is that the reading speed and fixation stability will be improved after training.

Eligibility criteria: Inclusion Criteria:

* Able to read Chinese.
* No formal vision rehabilitation training in reading after vision loss
* Diagnosis of diabetic macular oedema (DMO) and had previous treatment with laser and / or intravitreal injections
* Reasonable control of blood glucose level (HbA1c \<10) to minimize the impact of vision fluctuation
* Education level of 6 years or more (primary school or above)

Exclusion Criteria:

* Receive any types of eye treatments other than those mentioned above
* Any diagnosed ocular diseases other than DMO
* Severe medical problems or self reported neurological or cognitive disorders
* Serious hearing impairment
* Previously attended vision rehabilitation clinic

Primary outcomes:
measure: Change in visual processing speed
timeFrame: Change from baseline at week 6 and change from baseline at week 12 week
measure: Change in visual span size
timeFrame: Change from baseline at week 6 and change from baseline at week 12 week
Secondary outcomes:
measure: Change in reading performance
timeFrame: Change from baseline at week 6 and change from baseline at week 12 week
measure: Change in fixation stability
timeFrame: Change from baseline at week 6 and change from baseline at week 12 week
measure: Change in Chinese version of Impact of Visually Impaired (C-IVI) measure
timeFrame: Change from baseline at week 6 and change from baseline at week 12 week
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Allen MY Cheong
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Allen Ming Yan Cheong, PhD
role: PRINCIPAL_INVESTIGATOR
References: