Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema

Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema (DMO)- Randomized Controlled Trial

Sponsors

Lead Sponsor: The Hong Kong Polytechnic University

Collaborator: The University of Hong Kong

Source The Hong Kong Polytechnic University
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.

Overall Status Completed
Start Date 2015-05-01
Completion Date 2018-06-01
Primary Completion Date 2018-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in visual processing speed Change from baseline at week 6 and change from baseline at week 12 week
Change in visual span size Change from baseline at week 6 and change from baseline at week 12 week
Secondary Outcome
Measure Time Frame
Change in reading performance Change from baseline at week 6 and change from baseline at week 12 week
Change in fixation stability Change from baseline at week 6 and change from baseline at week 12 week
Change in Chinese version of Impact of Visually Impaired (C-IVI) measure Change from baseline at week 6 and change from baseline at week 12 week
Enrollment 55
Condition
Intervention

Intervention Type: Other

Intervention Name: Temporal Group

Description: Visual Processing Training

Arm Group Label: Temporal Group

Intervention Type: Other

Intervention Name: Spatial Group

Description: Spatial visual span training

Arm Group Label: Spatial Group

Intervention Type: Other

Intervention Name: Combined Group

Description: Visual processing speed and spatial visual span training

Arm Group Label: Combined Group

Intervention Type: Other

Intervention Name: Control Group

Description: Leisure reading activities

Arm Group Label: Control Group

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

Gender:

All

Minimum Age:

21 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Allen Ming Yan Cheong, PhD Principal Investigator The Hong Kong Polytechnic University
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Allen MY Cheong
Location Countries

China

Verification Date

2019-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The Hong Kong Polytechnic University

Investigator Full Name: Allen MY Cheong

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Temporal Group

Type: Active Comparator

Description: Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).

Label: Spatial Group

Type: Active Comparator

Description: Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).

Label: Combined Group

Type: Active Comparator

Description: Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).

Label: Control Group

Type: Placebo Comparator

Description: Receive 6 weekly 1-hour training sessions of leisure reading activities

Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Other

Masking: Single (Outcomes Assessor)

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