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

Diabetic Macular Oedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457884
• Other study ID #: 12131601
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 2018

Study information

• Verified date: February 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Oedema
• Edema
• Macular Edema
• Parafoveal Scotoma
• Scotoma

Intervention

Other:
• Temporal Group
Visual Processing Training
• Spatial Group
Spatial visual span training
• Combined Group
Visual processing speed and spatial visual span training
• Control Group
Leisure reading activities

Locations

Country	Name	City	State
China	Allen MY Cheong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual processing speed	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
Primary	Change in visual span size	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	Change in reading performance	Measured in three different ways for Chinese: Rapid serial visual presentation (RSVP); Sentence reading (MNREAD); Passage reading (IReST)	Change from baseline at week 6 and change from baseline at week 12 week
Secondary	Change in fixation stability	Fixation stability will be measured by MP-1 microperimeter.	Change from baseline at week 6 and change from baseline at week 12 week
Secondary	Change in Chinese version of Impact of Visually Impaired (C-IVI) measure	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