Efficacy of Lenses in Abolishing Photoparoxysmal Responses

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.

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.

Conditions

• Reflex Epilepsy, Photosensitive
• Eyeglasses

Interventions

DEVICE

Z1 lens

CE marked device

DEVICE

Experimental Lens 1

CE marked device

DEVICE

Experimental Lens 2

CE marked device

DEVICE

Experimental Lens 3

CE marked device

DEVICE

Experimental Lens 4

CE marked device

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust

  collaborator OTHER

• Aston University

  lead OTHER

Principal Investigators

• Bryony Carr, BSc · Birmingham Women's and Children's NHS Foundation Trust

• Ana Checa-Ros, MD, PhD · Aston University, Birmingham, UK

• Sukhvir Wright, MD, PhD · Aston University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-20

Primary Completion

2024-06-04

Completion

2026-01-31

Countries

• United Kingdom

Study Locations