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

Primary Purpose

Diabetic Macular Oedema, Parafoveal Scotoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Temporal Group
Spatial Group
Combined Group
Control Group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Macular Oedema focused on measuring Diabetic macular oedema, Perceptual learning, Chinese, Hong Kong

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allen MY Cheong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Temporal Group

Spatial Group

Combined Group

Control Group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in visual processing speed
Using trigrams to measure the character-recognition accuracy while characters are presented at different exposure times
Change in visual span size
Using trigrams to measure the character-recognition accuracy while characters are presented at different positions

Secondary Outcome Measures

Change in reading performance
Measured in three different ways for Chinese: Rapid serial visual presentation (RSVP) Sentence reading (MNREAD) Passage reading (IReST)
Change in fixation stability
Fixation stability will be measured by MP-1 microperimeter.
Change in Chinese version of Impact of Visually Impaired (C-IVI) measure
Self evaluated instrument to measure vision related restriction of participation in daily living.

Full Information

First Posted
May 25, 2015
Last Updated
February 21, 2019
Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02457884
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Oedema, Parafoveal Scotoma
Keywords
Diabetic macular oedema, Perceptual learning, Chinese, Hong Kong

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temporal Group
Arm Type
Active Comparator
Arm Description
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Arm Title
Spatial Group
Arm Type
Active Comparator
Arm Description
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Arm Title
Combined Group
Arm Type
Active Comparator
Arm Description
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Receive 6 weekly 1-hour training sessions of leisure reading activities
Intervention Type
Other
Intervention Name(s)
Temporal Group
Intervention Description
Visual Processing Training
Intervention Type
Other
Intervention Name(s)
Spatial Group
Intervention Description
Spatial visual span training
Intervention Type
Other
Intervention Name(s)
Combined Group
Intervention Description
Visual processing speed and spatial visual span training
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Leisure reading activities
Primary Outcome Measure Information:
Title
Change in visual processing speed
Description
Using trigrams to measure the character-recognition accuracy while characters are presented at different exposure times
Time Frame
Change from baseline at week 6 and change from baseline at week 12 week
Title
Change in visual span size
Description
Using trigrams to measure the character-recognition accuracy while characters are presented at different positions
Time Frame
Change from baseline at week 6 and change from baseline at week 12 week
Secondary Outcome Measure Information:
Title
Change in reading performance
Description
Measured in three different ways for Chinese: Rapid serial visual presentation (RSVP) Sentence reading (MNREAD) Passage reading (IReST)
Time Frame
Change from baseline at week 6 and change from baseline at week 12 week
Title
Change in fixation stability
Description
Fixation stability will be measured by MP-1 microperimeter.
Time Frame
Change from baseline at week 6 and change from baseline at week 12 week
Title
Change in Chinese version of Impact of Visually Impaired (C-IVI) measure
Description
Self evaluated instrument to measure vision related restriction of participation in daily living.
Time Frame
Change from baseline at week 6 and change from baseline at week 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Ming Yan Cheong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allen MY Cheong
City
Hong Kong
Country
China

12. IPD Sharing Statement

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

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