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Cochrane Database of Systematic Reviews Protocol - Intervention

Ocular interventions, excluding correction of significant refractive error, for specific reading disorder

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

The main aim of this review is to examine the effects of ocular interventions in SRD on reading speed and accuracy. We will also note any effect on comprehension.

Background

Introduction

Reading skills are defined as a proficiency in reading, developed through practice and influenced by ability. This includes word recognition, pronunciation and comprehension. Visual requirements accepted as necessary for reading are a clearly focused image on the retina maintained by accommodation (focusing), convergence (moving both eyes inwards) and pupil miosis (decrease in pupil size). There is also a need for an adequate saccadic system, the visual system which enables fast conjugate eye movements to fixate an object of interest on the fovea. This enables eye movements across the page and back to fixate on words or start a new line of print.

Specific reading disorder (SRD), also termed as specific developmental dyslexia or specific learning difficulties (SpLD), is a sub‐type of dyslexia and defined as a disorder manifested by difficulty in learning to read despite conventional instruction, adequate intelligence and socio‐cultural opportunity (Chritchley 1970). There is no universal definition of dyslexia but the former is from the World Federation of Neurology and is the most widely used. An alternative definition describes SRD as present when the automatisation of word identification (reading) and/or word spelling does not develop, or does so very incompletely or with great difficulty (Gersons 1997). This definition does not exclude those children with an intelligence quotient (IQ) at the lower end of normal where a reduction in reading ability may simply be viewed as in line with their intelligence. Specific reading disorder is often defined on the basis of a discrepancy between IQ and standard reading scores (Newsham 2001). It can exist in normal children where there is a significant difference between reading age and chronological age.

Specific reading disorder is a complex learning difficulty because of the number of characteristics associated with it. These vary from individual to individual and not all will exhibit signs or symptoms of ocular defects. It is the purpose of this review to examine only those people with SRD who have been identified as having ocular signs and symptoms.

Epidemiology

Dyslexia affects 5 to 10% of school populations, according to the British Dyslexia Association. The incidence varies according to the threshold adopted for identification of the condition (Lennerstrand 1992). It is a multicultural problem although it is more prevalent in English speaking countries due to the complexities of language construction and left to right reading. A study of English, French and Italian dyslexics concluded that there is a universal neurocognitive basis for dyslexia and that differences in reading performance among dyslexics of different countries are due to different orthographies (systems of spelling) (Paulesu 2001). However a Chinese study stated that biological abnormalities of impaired reading are constrained by culture (Siok 2004) Dyslexia is often familial (Chase 1996) and is thought to be more prevalent in males (Katusic 2001). It is accepted that SRD with associated ocular signs and symptoms occurs in a small percentage of the dyslexic population but the precise incidence is unknown.
The causes of SRD are still debated. Some believe that eye defects are a consequence of and not a cause of reading disability. However others have suggested mechanisms for primary ocular defects as outlined below:

  • anatomical and physiological abnormalities in both language and visual areas of the brain (Demb 1998);

  • small cerebral haemorrhages; increased risk in premature babies (Newsham 2001);

  • defects of motor perception often associated with other motor defects i.e. dyspraxia (poor co‐ordination and balance) (Nicolson 1999);

  • defects in processing of retinal and extra‐retinal signals (magnocellular and parvocellular pathways) (Stein 1997);

  • saccadic dysmetria (impairment of the saccadic system) (Biscaldi 1998);

  • a disturbance of the smooth pursuit system preventing steady fixation on words when reading (Raymond 1988);

  • genetic factors, although no specific dyslexia gene has been found (Nopola‐Hemmi 2001).

Although SRD can exist without any other developmental problems it has now been linked with other pervasive disorders, in particular attention deficit hyperactivity disorder (ADHD) and dyspraxia (Richardson 2001). Finally some believe retention of primitive survival reflexes inhibit the development of reading through maintaining the correct posture (McPhillips 2000).

Presentation and diagnosis

Specific reading disorder with ocular signs and symptoms will present as difficulty in learning to read with additional symptoms of headaches, glare from print or awareness of print movement. Frequently sufferers will have difficulty in following a line of print or may lose their place when beginning a new line. There may be other developmental or behavioral problems.

Ocular signs can include one or all of the following:

  • poor convergence ‐ the ability to move the eyes disjugately to maintain binocular fixation on a near object;

  • poor binocular control ‐ the ability to use two eyes together to maintain a single image with fusion and stereopsis;

  • poor tracking ‐ ability to follow a slow moving target, known as smooth pursuit. This helps to maintain fixation on a single target;

  • incomplete saccades ‐ voluntary movements of the eyes to change fixation from one object, or word, to another;

  • a lack of a reference eye when reading. This is not the same as a dominant eye used in preference when using monocular viewing;

  • poor ability to focus (accommodation).

Symptoms may include:

  • pattern glare or severe discomfort when reading often associated with headaches, also known as Meares‐Irlen syndrome. The cause of this is controversial but is said to be a defect of the colour receptors in the retina;

  • movement and blurring of letters. Awareness of moving print can also be caused by defects in motion linked with travel sickness;

  • diplopia (double vision);

  • blurred vision;

  • headaches, particularly of the migraine type.

A diagnosis of SRD is made by comparing verbal IQ with reading ability and comprehension based on the averages for chronological age. SRD is unlikely to be diagnosed before eight years of age as many normal children struggle with reading in their formative years. Poor reading may be considered to be in line with IQ. Detection may be hindered as optometrists, orthoptists and ophthalmologists are not always trained to look for ocular defects specifically associated with reading difficulties and the detection of ocular motility disorders does not form part of the educational assessment of a child with reading difficulties. As a result concerned parents may have problems finding a suitably qualified specialist, for which cost can be prohibitive. Specialist clinics do exist and referral is usually made to an orthoptist or behavioural optometrist via school, paediatricians or general practitioners. However, there is no standard practice for referral of dyslexics for specialised ocular examinations.

Treatment options

Specific reading disorder is thought normally to persist into adult life. However, there are many therapies used to cope with this disorder. Because impaired eye movements are frequently noted in this group, claims are made that ocular exercises should be used in treatment. Treatment aims to improve reading speed by improving ocular stability and comfort therefore assisting in comprehension through better ability to concentrate for prolonged periods.

There are several ocular interventions used in the treatment of SRD. The treatment used will depend on the ocular findings during history taking and examination. The most common are listed below.

  • Exercises to improve convergence and/or accommodation, helping to reduce fatigue and maintain binocular viewing.

  • Plus lenses to aid accommodation (focusing).

  • Prisms and physiological diplopia exercises to improve positive and negative fusional vergences i.e. motor fusion (the ability to maintain a single fused image in binocular viewing).

  • Tracking exercises (eye gym) to improve the ability to fixate on an object and follow an object across the field of vision. This also improves saccadic movement aiding in moving eyes to a new word or line of print.

  • Occlusion therapy to establish a reference eye in binocular viewing to eliminate confusion resulting in jumping of print when reading.

  • Coloured overlays placed directly on reading print or in tinted spectacle correction to eliminate glare (Meares‐Irlen syndrome).

  • Filters to aid motion defects, usually yellow or blue. These defects are often associated with dyspraxia.

Some treatments may become permanent as in coloured overlays or tinted spectacles; other treatments may only be used temporarily.

Rationale for a systematic review

There is significant controversy about the effectiveness of ocular interventions in SRD. Many treatments are expensive and are not universally available. A systematic review will clarify the evidence on ocular interventions and their effectiveness on reading. Being able to clarify whether particular interventions work, and on which particular ocular signs and symptoms, will help to focus treatment on those likely to benefit from ocular treatment and prevent unnecessary and often costly treatment of those unlikely to benefit.

Objectives

The main aim of this review is to examine the effects of ocular interventions in SRD on reading speed and accuracy. We will also note any effect on comprehension.

Methods

Criteria for considering studies for this review

Types of studies

This review will include randomised controlled trials of participants with SRD who are identified as having two or more of the signs or symptoms of ocular defects as listed above. The studies will include any ocular interventions that meet the inclusion criteria.

Types of participants

Participants will be children and adults with specific reading disorder (SRD) and clinical signs or symptoms of ocular involvement as previously outlined. Adults and children of eight years and over of either gender will be included. Children under the age of eight years will be excluded due to the difficulty of accurate assessment in this age group. Participants will have had significant refractive error and/or strabismus (squint) corrected or eliminated as a causative factor. Where trials include children and adults, we will contact the authors for further information so that we can separate the data for the two groups.

Types of interventions

We will include trials in which any of the following interventions have been compared to no treatment or to each other:
(1) convergence and/or accommodation exercises;
(2) plus lenses;
(3) prisms and physiological diplopia exercises;
(4) tracking exercises (eye gym);
(5) occlusion therapy;
(6) coloured overlays or tinted spectacle correction to eliminate glare;
(7) filters to aid motion defects, usually yellow or blue.

Participants may be receiving other non‐ocular treatments but these must also be used in any control group. This review will not consider treatment of significant refractive errors or strabismus (squint) as these are common ocular signs, not necessarily associated with poor reading, and treatment is widely available.

Types of outcome measures

Primary outcomes

The two main outcome measures for this review will be change in reading speed and reading accuracy as measured by any clearly validated testing method. As the Wilkins Rate of Reading test is a well recognised and frequently used method of assessment, data using this test will be extracted and subject to sensitivity analysis. Comparison will be made between reading speed and accuracy pre‐ and post ocular intervention with control groups and/or other ocular interventions.
Reading speed is likely to be individual and measure of successful treatment will be dependant on the increase before and after intervention.

Secondary outcomes

Secondary outcome will be change in reading comprehension. The review authors are not able to identify the tests used in assessing comprehension as this is an educational testing procedure not used in medical clinics. Where trials include results of comprehension we will look at these in detail and if the results are comparable we will enter them into the analysis. If the methods of testing are not comparable the review authors will comment on any documentation. Comprehension will be assessed on normal distribution on given age ranges.

Adverse effects (severe, minor)

Adverse effects are not anticipated with these interventions but any found in reviews will be noted, including psychological effects and cost of treatments.

Quality of life measures

We will note any improvement in reading ability resulting in better school/work performance. There may also be measures of improvement in symptoms allowing better concentration and behaviour.

Economic data

We will include any data on costs of treatments.

Follow up

A minimum follow‐up of six months will be specified to establish sustained effect. Studies will have results within one year of beginning treatment. This should be sufficient time to establish any improvement in the secondary outcome of comprehension. It is also likely that change in reading speed and accuracy will be demonstrable within this minimum follow up time.

The review authors will comment on any treatments that provide sustained improvement without further intervention and those where treatment is on going.

Search methods for identification of studies

Electronic searches

Trials will be identified from the Cochrane Central Register of Controlled Trials ‐ CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) in The Cochrane Library, MEDLINE, EMBASE and Latin American and Caribbean Literature on Health Sciences (LILACS). There will be no date or language restrictions.

See: Appendices for details of search strategies for each database.

Searching other resources

We will search the references lists of the studies included in the review for information about further trials. We will contact professionals who specialise in this area for further details of published or unpublished trials that may be relevant to the review. We will not handsearch journals or conference proceedings specifically for this review. Journals covering this subject are more likely to be found in educational or psychological journals with which the reviewers are unfamiliar.

Data collection and analysis

Assessment of search results

Three review authors will screen the titles and abstracts of the reports of studies identified in the electronic searches. The full copies of possibly or definitely relevant studies will be obtained for further assessment. They will be assessed by all the authors who will check if the studies meet the inclusion criteria. Any disagreements will be resolved through discussion. All three review authors will search the reference lists of the studies included in the review for information about other trials.

Assessment of methodological quality

Three review authors will assess methodological quality and any disagreements will be resolved by discussion. We will follow the recommendations for assessing methodological quality given by the Cochrane Eyes and Vision Group based on the Cochrane Reviewers' Handbook (Alderson 2004). We will assess the following parameters:

(1) Selection bias
The method of random allocation to the study will be reviewed to ensure adequate concealment. Interventions should be prescribed once randomisation has been completed.
(2) Performance bias
This will look at the method of masking of participants and researchers. Performance assessors should be unaware of the intervention being received. There may be some difficulty in providing a placebo for some of the ocular interventions therefore masking of participants in the trials will be given a high grading.
(3) Detection bias
Effectiveness of method of masking/blinding the examiner to treatment allocation will be evaluated.
(4) Attrition bias
Analysis of randomised subjects by intention to treat (ITT) and reports of excluded subjects. The completeness of follow up of all the trial participants will be analysed and where there is poor reporting of protocol deviations, dropouts or withdrawals from treatment the study will be graded as poor quality.

Each of the above parameters will be graded A ‐adequate B ‐unclear C ‐ inadequate. Authors will be contacted if any of the parameters are unclearly described in the trial.

Data collection

We will use a pre‐specified extraction form that has been piloted before being applied to all studies. We will resolve discrepancies by referring to the original papers and discussion. Information extracted will include methods, participants, interventions and outcomes. We will contact authors where data is incomplete or inadequate for the review.

Data synthesis

Trials included in the review will be checked for homogeneity and, if appropriate, meta‐analysis will be carried out. This will be done using Review Manager 4.2. Where there is heterogeneity a descriptive summary of results will be given.

We anticipate there will be two sets of data: intervention versus no treatment and one intervention versus another intervention. If this is the case these will be summarised separately. Where outcomes are dichotomous we will use odds ratio or relative risk ratio and for continuous data we will use the weighted mean difference. Where outcome measurements use different instruments, similar enough to be combined, we will present the standardised mean difference.

Sensitivity analysis

Sensitivity analysis will be conducted on the summary effect of the review by excluding trials of lower methodological quality, unpublished studies and also where the Wilkins Rate of Reading test has been used.