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

NCT ID: NCT02457884

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Diabetic Macular Oedema Parafoveal Scotoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Temporal Group

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

Group Type ACTIVE_COMPARATOR

Temporal Group

Intervention Type OTHER

Visual Processing Training

Spatial Group

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

Group Type ACTIVE_COMPARATOR

Spatial Group

Intervention Type OTHER

Spatial visual span training

Combined Group

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

Group Type ACTIVE_COMPARATOR

Combined Group

Intervention Type OTHER

Visual processing speed and spatial visual span training

Control Group

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

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

Leisure reading activities

Interventions

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Temporal Group

Visual Processing Training

Intervention Type OTHER

Spatial Group

Spatial visual span training

Intervention Type OTHER

Combined Group

Visual processing speed and spatial visual span training

Intervention Type OTHER

Control Group

Leisure reading activities

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Allen MY Cheong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allen Ming Yan Cheong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Allen MY Cheong

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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12131601

Identifier Type: -

Identifier Source: org_study_id

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