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

T

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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