Efficacy of Lenses in Abolishing Photoparoxysmal Responses

NCT04076410 | Active Not Recruiting

• 3 other identifiers: 284-2019-CR26649720/EM/0030
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

• 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.

Conditions

Reflex Epilepsy, Photosensitive; Eyeglasses

Keywords

photosensitivity; pattern sensitivity; Electroencephalography; Photic Stimulation; Pattern Stimulation; photoparoxysmal response; Light, Visible; Red Colour; Blue Light; children; epilepsy; standardized photoparoxysmal response range

Outcome Measures

Primary Outcomes (2)

• PPR change

  Relative change in the photoparoxysmal response grade

  Baseline (First visit T0)

• SPR change

  Relative change in the standardized photoparoxysmal response range (SPR)

  Baseline (First visit T0)

Secondary Outcomes (1)

• Adherence and tolerability to lenses in everyday life

  6 months after acquiring the lenses (T6)

Study Arms (1)

5 Lenses

EXPERIMENTAL

The five lenses will be tested in each patient following always the same specific order, with the most protective lenses tested first (Z1). Z1F133 (Zeiss Clarlet Z1) is a CE marked device manufactured by Carl Zeiss Vision International GmBH (Aalen, Germany). Our lenses are CE marked devices manufactured by Cerium Optical Products (Kent, UK).

Device: Z1 lens; Device: Experimental Lens 1; Device: Experimental Lens 2; Device: Experimental Lens 3; Device: Experimental Lens 4

Interventions

Z1 lens DEVICE

CE marked device

Also known as: Zeiss F133

5 Lenses

Experimental Lens 1 DEVICE

CE marked device

5 Lenses

Experimental Lens 2 DEVICE

CE marked device

5 Lenses

Experimental Lens 3 DEVICE

CE marked device

5 Lenses

Experimental Lens 4 DEVICE

CE marked device

5 Lenses

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents between 5-18 years with suspected or confirmed diagnosis of photosensitive epilepsy (PSE), whether they are taking antiepileptic medication or not.
• 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.

You may not qualify if:

• 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
• Refusal to participate
• Generalized seizure during the EEG procedure.
• Female patients suspected or known to be pregnant.

Sponsors & Collaborators

• Aston University: lead
• Birmingham Women's and Children's NHS Foundation Trust: collaborator

Study Sites (2)

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, West Midlands, B4 6NH, United Kingdom

Location

Aston University

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

Related Publications (10)

• Capovilla G, Beccaria F, Romeo A, Veggiotti P, Canger R, Paladin F. Effectiveness of a particular blue lens on photoparoxysmal response in photosensitive epileptic patients. Ital J Neurol Sci. 1999 Jun;20(3):161-6. doi: 10.1007/s100720050026.

  PMID: 10541598 BACKGROUND

• Capovilla G, Gambardella A, Rubboli G, Beccaria F, Montagnini A, Aguglia U, Canevini MP, Casellato S, Granata T, Paladin F, Romeo A, Stranci G, Tinuper P, Veggiotti P, Avanzini G, Tassinari CA. Suppressive efficacy by a commercially available blue lens on PPR in 610 photosensitive epilepsy patients. Epilepsia. 2006 Mar;47(3):529-33. doi: 10.1111/j.1528-1167.2006.00463.x.

  PMID: 16529617 BACKGROUND

• Fisher RS, Harding G, Erba G, Barkley GL, Wilkins A; Epilepsy Foundation of America Working Group. Photic- and pattern-induced seizures: a review for the Epilepsy Foundation of America Working Group. Epilepsia. 2005 Sep;46(9):1426-41. doi: 10.1111/j.1528-1167.2005.31405.x.

  PMID: 16146439 BACKGROUND

• Guerrini R, Genton P. Epileptic syndromes and visually induced seizures. Epilepsia. 2004;45 Suppl 1:14-8. doi: 10.1111/j.0013-9580.2004.451011.x.

  PMID: 14706039 BACKGROUND

• Harding, G., & Jeavons, P. (1994). Photosensitive Epilepsy: Clinics in Developmental Medicine. London, UK: McKeith Press.

  BACKGROUND

• Kasteleijn-Nolst Trenite D, Rubboli G, Hirsch E, Martins da Silva A, Seri S, Wilkins A, Parra J, Covanis A, Elia M, Capovilla G, Stephani U, Harding G. Methodology of photic stimulation revisited: updated European algorithm for visual stimulation in the EEG laboratory. Epilepsia. 2012 Jan;53(1):16-24. doi: 10.1111/j.1528-1167.2011.03319.x. Epub 2011 Nov 16.

  PMID: 22091642 BACKGROUND

• Mainster MA. Violet and blue light blocking intraocular lenses: photoprotection versus photoreception. Br J Ophthalmol. 2006 Jun;90(6):784-92. doi: 10.1136/bjo.2005.086553.

  PMID: 16714268 BACKGROUND

• Quirk JA, Fish DR, Smith SJ, Sander JW, Shorvon SD, Allen PJ. Incidence of photosensitive epilepsy: a prospective national study. Electroencephalogr Clin Neurophysiol. 1995 Oct;95(4):260-7. doi: 10.1016/0013-4694(95)00118-i.

  PMID: 8529557 BACKGROUND

• Verrotti A, Grosso S, D'Egidio C, Parisi P, Spalice A, Pavone P, Capovilla G, Agostinelli S. Valproate in adolescents with photosensitive epilepsy with generalized tonic-clonic seizures only. Eur J Paediatr Neurol. 2014 Jan;18(1):13-8. doi: 10.1016/j.ejpn.2013.06.006. Epub 2013 Jul 26.

  PMID: 23891468 BACKGROUND

• Yalcin AD, Kaymaz A, Forta H. Reflex occipital lobe epilepsy. Seizure. 2000 Sep;9(6):436-41. doi: 10.1053/seiz.2000.0424.

  PMID: 10986003 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Reflex; Photosensitivity Disorders; Erythema; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryony Carr, BSc

  Birmingham Women's and Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Ana Checa-Ros, MD, PhD

  Aston University, Birmingham, UK

  PRINCIPAL INVESTIGATOR

• Sukhvir Wright, MD, PhD

  Aston University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Research Fellow

Model Details: Participants will be recruited among those patients (both males and females) from 5 to 18 years with suspected or confirmed diagnosis of generalised epilepsy with photosensitivity or photosensitive epilepsy (PSE) who comply with the established inclusion criteria. No control patients will be required, since each patient will be tested with the different lenses in a specific order and will be, in turn, his/her own control. No randomisation will be carried out in our study.

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 3, 2019
• Study Start: February 20, 2021
• Primary Completion: June 4, 2024
• Study Completion: January 31, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)