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Completed

NCT Number: NCT02457884

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

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allen MY Cheong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporal Group

Other

Visual Processing Training

Spatial Group

Other

Spatial visual span training

Combined Group

Other

Visual processing speed and spatial visual span training

Control Group

Other

Leisure reading activities

Primary outcomes

  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 outcomes

  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:

    • Rapid serial visual presentation (RSVP)
    • Sentence reading (MNREAD)
    • 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • The University of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 29, 2015
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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