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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Diabetic Macular Oedema; Parafoveal Scotoma

Treatments: Other: Control Group; Other: Temporal Group; Other: Spatial Group; Other: Combined Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02457884

12131601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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55 participants in 4 patient groups, including a placebo group

Temporal Group

Active Comparator group

Description:

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

Treatment:

Other: Temporal Group

Spatial Group

Active Comparator group

Description:

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

Treatment:

Other: Spatial Group

Combined Group

Active Comparator group

Description:

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

Treatment:

Other: Combined Group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Control Group