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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457884
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Allen MY Cheong, 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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Oedema Parafoveal Scotoma Other: Temporal Group Other: Spatial Group Other: Combined Group Other: Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema (DMO)- Randomized Controlled Trial
Actual Study Start Date : May 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Rehabilitation

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457884


Locations
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China
Allen MY Cheong
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
The University of Hong Kong
Investigators
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Principal Investigator: Allen Ming Yan Cheong, PhD The Hong Kong Polytechnic University

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Responsible Party: Allen MY Cheong, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02457884    
Other Study ID Numbers: 12131601
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Keywords provided by Allen MY Cheong, The Hong Kong Polytechnic University:
Diabetic macular oedema
Perceptual learning
Chinese
Hong Kong
Additional relevant MeSH terms:
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Scotoma
Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases