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

Not Applicable

Completed

• Conditions: Diabetic Macular Oedema; Parafoveal Scotoma
• Interventions: Other: Temporal Group; Other: Control Group; Other: Spatial Group; Other: Combined Group

• Registration Number: NCT02457884
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-05-29
• Primary Completion: 2018-03
• Study Completion: 2018-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Temporal Group	Temporal Group	Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Control Group	Control Group	Receive 6 weekly 1-hour training sessions of leisure reading activities
Spatial Group	Spatial Group	Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
Combined Group	Combined Group	Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).

Primary Outcome Measures

Name	Time	Method
Change in visual processing speed	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 in visual span size	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

Name	Time	Method
Change in reading performance	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 in fixation stability	Change from baseline at week 6 and change from baseline at week 12 week	Fixation stability will be measured by MP-1 microperimeter.
Change in Chinese version of Impact of Visually Impaired (C-IVI) measure	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.

Trial Locations

Locations (1)

Allen MY Cheong; 🇨🇳 Hong Kong, China