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

February 21, 2019 updated by: Allen MY Cheong, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Allen MY Cheong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Temporal Group
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Other: Temporal Group
Visual Processing Training
Active Comparator: Spatial Group
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Other: Spatial Group
Spatial visual span training
Active Comparator: Combined Group
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Other: Combined Group
Visual processing speed and spatial visual span training
Placebo Comparator: Control Group
Receive 6 weekly 1-hour training sessions of leisure reading activities
Other: Control Group
Leisure reading activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual processing speed
Time Frame: Change from baseline at week 6 and change from baseline at week 12 week
Using trigrams to measure the character-recognition accuracy while characters are presented at different exposure times
Change from baseline at week 6 and change from baseline at week 12 week
Change in visual span size
Time Frame: Change from baseline at week 6 and change from baseline at week 12 week
Using trigrams to measure the character-recognition accuracy while characters are presented at different positions
Change from baseline at week 6 and change from baseline at week 12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reading performance
Time Frame: Change from baseline at week 6 and change from baseline at week 12 week

Measured in three different ways for Chinese:

  1. Rapid serial visual presentation (RSVP)
  2. Sentence reading (MNREAD)
  3. Passage reading (IReST)
Change from baseline at week 6 and change from baseline at week 12 week
Change in fixation stability
Time Frame: Change from baseline at week 6 and change from baseline at week 12 week
Fixation stability will be measured by MP-1 microperimeter.
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
Time Frame: Change from baseline at week 6 and change from baseline at week 12 week
Self evaluated instrument to measure vision related restriction of participation in daily living.
Change from baseline at week 6 and change from baseline at week 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Allen Ming Yan Cheong, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12131601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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