Eyeglasses Clinical Trial
— PPRsOfficial title:
Efficacy of New Lenses in Abolishing Photoparoxysmal Responses in Paediatric Patients With Photosensitive Epilepsy (PSE)
Verified date | June 2024 |
Source | Aston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background. Blue lenses that filter out red light have been proposed as a new therapeutic alternative for patients with PSE, such as the lens Zeiss Clarlet Z1. This lens only allows a small overall quantity of visible light, and particularly a minimum percentage of red light, to pass through. However, these characteristics entail two main pitfalls: reduced applicability in high- latitude regions and lack of transmission for the red and yellow colors. The latter would mainly expose patients to the other colors that compose the visible light, and particularly to the blue visible light. This exposure might be damaging for their eyes in the long term, as it has been reported in some studies. Aim. To determine whether four new lenses with different spectral characteristics are not inferior in efficacy to Z1 to reduce the PPRs in patients with PSE. Participants. Patients between 5-18 years with suspected or confirmed PSE, referred to the Neurophysiology Service at Birmingham Children's Hospital (BCH) for an EEG with IPS/pattern stimulation. Objectives & Outcomes: 1.A) Primary Objective: To evaluate the reduction/suppression produced by four new lenses in the PPRs shown by patients with PSE during an EEG with IPS/pattern stimulation, and compare it with the reduction provoked by the Z1 lens in the same individuals. 1. B) Primary Outcome: reduction/suppression in both the PPR and the standardized photoparoxysmal response range (SPR) for IPS and pattern stimulation. 2. A) Secondary Objectives: - To obtain feedback from the patients who acquire a pair of our lenses regarding tolerability, overall adherence to treatment and improvement in the quality of life. - Comparison of the reduction/suppression in the PPRs between our lenses and the Z1 lens in those retrospective patients with PSE seen between 2008-2017 at the Aston Brain Center. 2.B) Secondary Outcomes: - Mean score obtained in adherence to treatment, tolerability, reduction in seizure frequency and autonomy according to the patient/parents or carers satisfaction questionnaires. - Reduction/suppression in both the PPR and the standardized photoparoxysmal response range (SPR) for IPS and pattern stimulation in those patients recruited at the Aston Brain Center.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | January 31, 2026 |
Est. primary completion date | June 4, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | 1. Inclusion Criteria: 1. Children and adolescents between 5-18 years with suspected or confirmed diagnosis of photosensitive epilepsy (PSE), whether they are taking antiepileptic medication or not. 2. Capacity to: - maintain concentration during the procedure - follow simple commands - assent (under 16 years) or consent (16-18 years) to participate after understanding the purpose of the study. 2. Exclusion Criteria: 1. Presence of a condition that may compromise the ability to tolerate the procedure and/or the capacity to assent or consent, such as: - intellectual disability - attention-deficit/hyperactivity disorder - autism spectrum disorders - difficulties to understand verbal/written explanations in English 2. Refusal to participate 3. Generalized seizure during the EEG procedure. 4. Female patients suspected or known to be pregnant. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aston University | Birmingham | West Midlands |
United Kingdom | Birmingham Women's and Children's NHS Foundation Trust | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
Aston University | Birmingham Women's and Children's NHS Foundation Trust |
United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PPR change | Relative change in the photoparoxysmal response grade | Baseline (First visit T0) | |
Primary | SPR change | Relative change in the standardized photoparoxysmal response range (SPR) | Baseline (First visit T0) | |
Secondary | Adherence and tolerability to lenses in everyday life | The score obtained in the different sections of the Patient Satisfaction Questionnaire [on a scale from 1 (worst outcome) to 5 (best outcome)] | 6 months after acquiring the lenses (T6) |
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