NCT04076410: PPRs

Efficacy of Lenses in Abolishing Photoparoxysmal Responses

Active, enrolled NA Last updated 5 June 2024

What this trial tests

NA trial testing Z1 lens in Reflex Epilepsy, Photosensitive in 28 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 February 2021

Primary endpoint
4 June 2024

31 January 2026

Quick facts

Lead sponsor	Aston University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	20 February 2021
Primary completion	4 June 2024
Estimated completion	31 January 2026
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Z1 lens
• Experimental Lens 1
• Experimental Lens 2
• Experimental Lens 3
• Experimental Lens 4

Conditions studied

• Reflex Epilepsy, Photosensitive — all drugs for Reflex Epilepsy, Photosensitive →
• Eyeglasses — all drugs for Eyeglasses →

Sponsor

Aston University

Who can join

Adults 5 to 18, any sex, with Reflex Epilepsy, Photosensitive or Eyeglasses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults.
   Singh S, Keller PR, Busija L, McMillan P, et al · · 2023 · cited 23× · PMID 37593770 · DOI 10.1002/14651858.cd013244.pub2