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A multicentre phase III randomised controlled single-masked clinical trial evaluating the clinical efficacy and safety of light-masks at preventing dark-adaptation in the treatment of early diabetic macular oedema (CLEOPATRA): study protocol for a randomised controlled trial.

Sivaprasad S, Arden G, Prevost AT, Crosby-Nwaobi R, Holmes H, Kelly J, Murphy C, Rubin G, Vasconcelos J, Hykin P - Trials (2014)

Bottom Line: Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula, macular volume, refracted visual acuity and level of retinopathy.Safety parameters will include sleep disturbance.The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple, non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes.

View Article: PubMed Central - PubMed

Affiliation: NIHR Moorfields Biomedical Research Centre, 162, City Road, London EC1V 2PD, England. senswathi@aol.com.

ABSTRACT

Background: This study will evaluate hypoxia, as a novel concept in the pathogenesis of diabetic macular oedema (DMO). As the oxygen demand of the eye is maximum during dark-adaptation, we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO. The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis.

Method/design: This is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO. Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks (with no light) to be used during sleep at night for a period of 24 months. The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography (SD-OCT). Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula, macular volume, refracted visual acuity and level of retinopathy. Safety parameters will include sleep disturbance. Adverse events and measures of compliance will be assessed over 24 months. Participants recruited to the mechanistic sub-study will have additional retinal oximetry, multifocal electroretinography (ERG) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at 12 months.

Discussion: The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple, non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes.

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Related in: MedlinePlus

Flow diagram of the CLEOPATRA trial. The flow diagram shows the patient flow through the period of the trial and includes the mechanistic evaluation done at one site only.
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Fig1: Flow diagram of the CLEOPATRA trial. The flow diagram shows the patient flow through the period of the trial and includes the mechanistic evaluation done at one site only.

Mentions: This is a phase III randomised controlled single-masked clinical trial that will evaluate the efficacy and safety of light-masks in treating and preventing the progression of non-centre-involving DMO. Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks (with no light) to be used during sleep at night for a period of 24 months. This basic study design and the associated clinical measurements are well-established, having been successfully used in numerous previous clinical trials of DMO. These include visual acuity and retinal thickness measurements using SD-OCT every 4 months, refracted visual acuity, retinal colour photographs, blood pressure, glycosylated haemoglobin (HbA1c), Pittsburgh Insomnia Rating Score[11] and Epworth Sleepiness Scale[12] questionnaires to assess sleep at baseline, 12 and 24 months, adverse events and measures of compliance at all 8 study visits over 24 months. Best corrected visual acuity will be repeated at baseline and SD-OCT assessment will be done twice at 12 and 24 months to assess inter-test variability. Participants recruited to the mechanistic evaluation will have additional retinal oximetry, multifocal ERG and microperimetry at baseline and 12 months. Please see visit schedules (Table 1) and study flow diagram (Figure 1). At least 15 sites in England and Wales will be participating in this study. Kings Clinical Trials Unit (KCTU) is the co-ordinating centre. The study has been approved by the National Research Ethics Service Committee London - Dulwich (Ref: 13/LO/0145).Table 1


A multicentre phase III randomised controlled single-masked clinical trial evaluating the clinical efficacy and safety of light-masks at preventing dark-adaptation in the treatment of early diabetic macular oedema (CLEOPATRA): study protocol for a randomised controlled trial.

Sivaprasad S, Arden G, Prevost AT, Crosby-Nwaobi R, Holmes H, Kelly J, Murphy C, Rubin G, Vasconcelos J, Hykin P - Trials (2014)

Flow diagram of the CLEOPATRA trial. The flow diagram shows the patient flow through the period of the trial and includes the mechanistic evaluation done at one site only.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4255925&req=5

Fig1: Flow diagram of the CLEOPATRA trial. The flow diagram shows the patient flow through the period of the trial and includes the mechanistic evaluation done at one site only.
Mentions: This is a phase III randomised controlled single-masked clinical trial that will evaluate the efficacy and safety of light-masks in treating and preventing the progression of non-centre-involving DMO. Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks (with no light) to be used during sleep at night for a period of 24 months. This basic study design and the associated clinical measurements are well-established, having been successfully used in numerous previous clinical trials of DMO. These include visual acuity and retinal thickness measurements using SD-OCT every 4 months, refracted visual acuity, retinal colour photographs, blood pressure, glycosylated haemoglobin (HbA1c), Pittsburgh Insomnia Rating Score[11] and Epworth Sleepiness Scale[12] questionnaires to assess sleep at baseline, 12 and 24 months, adverse events and measures of compliance at all 8 study visits over 24 months. Best corrected visual acuity will be repeated at baseline and SD-OCT assessment will be done twice at 12 and 24 months to assess inter-test variability. Participants recruited to the mechanistic evaluation will have additional retinal oximetry, multifocal ERG and microperimetry at baseline and 12 months. Please see visit schedules (Table 1) and study flow diagram (Figure 1). At least 15 sites in England and Wales will be participating in this study. Kings Clinical Trials Unit (KCTU) is the co-ordinating centre. The study has been approved by the National Research Ethics Service Committee London - Dulwich (Ref: 13/LO/0145).Table 1

Bottom Line: Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula, macular volume, refracted visual acuity and level of retinopathy.Safety parameters will include sleep disturbance.The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple, non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes.

View Article: PubMed Central - PubMed

Affiliation: NIHR Moorfields Biomedical Research Centre, 162, City Road, London EC1V 2PD, England. senswathi@aol.com.

ABSTRACT

Background: This study will evaluate hypoxia, as a novel concept in the pathogenesis of diabetic macular oedema (DMO). As the oxygen demand of the eye is maximum during dark-adaptation, we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO. The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis.

Method/design: This is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO. Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks (with no light) to be used during sleep at night for a period of 24 months. The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography (SD-OCT). Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula, macular volume, refracted visual acuity and level of retinopathy. Safety parameters will include sleep disturbance. Adverse events and measures of compliance will be assessed over 24 months. Participants recruited to the mechanistic sub-study will have additional retinal oximetry, multifocal electroretinography (ERG) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at 12 months.

Discussion: The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple, non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes.

Show MeSH
Related in: MedlinePlus