Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04076410
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2019-08-30
Brief Title:
Efficacy of Lenses in Abolishing Photoparoxysmal Responses
Sponsor:
Aston University
Organization:
Aston University
Study Overview
Official Title:
Efficacy of New Lenses in Abolishing Photoparoxysmal Responses in Paediatric Patients With Photosensitive Epilepsy PSE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPRs
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 Childrens Hospital BCH for an EEG with IPSpattern stimulation
Objectives Outcomes
1A Primary Objective To evaluate the reductionsuppression produced by four new lenses in the PPRs shown by patients with PSE during an EEG with IPSpattern stimulation and compare it with the reduction provoked by the Z1 lens in the same individuals
1 B Primary Outcome reductionsuppression 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 reductionsuppression 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
2B Secondary Outcomes
Mean score obtained in adherence to treatment tolerability reduction in seizure frequency and autonomy according to the patientparents or carers satisfaction questionnaires
Reductionsuppression 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
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 Childrens Hospital BCH for an EEG with IPSpattern stimulation
Objectives Outcomes
1A Primary Objective To evaluate the reductionsuppression produced by four new lenses in the PPRs shown by patients with PSE during an EEG with IPSpattern stimulation and compare it with the reduction provoked by the Z1 lens in the same individuals
1 B Primary Outcome reductionsuppression 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 reductionsuppression 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
2B Secondary Outcomes
Mean score obtained in adherence to treatment tolerability reduction in seizure frequency and autonomy according to the patientparents or carers satisfaction questionnaires
Reductionsuppression 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
Detailed Description:
1 BACKGROUND
Photosensitive epilepsy PSE is the most common of reflex epilepsies and represents approximately 10 of all new cases of epilepsy in the age range 7-19 years Harding Jeavons 1994 Photosensitivity is the nuclear feature of PSE in which seizures are provoked by light stimuli or visual patterns such as lines gratings or checkerboards Yalçin Kaymaz Forta 2000Fisher Harding Erba Barkley Wilkins 2005 Therefore usual external triggers of seizures in the daily life of patients with PSE are sunlight and screens like televisions TVs video games and computer displays Photicpattern sensitivity can be detected on the electroencephalogram EEG by the presence of a specific abnormality called the photoparoxysmal response PPR which is usually evoked by intermittent photic stimulation IPS or pattern stimulation respectively Quirk et al 1995 Red color wavelength around 600-700nm has been proposed to be the most provocative stimulus among the primary colors to trigger photosensitivitypattern-sensitivity in these patients Fisher et al 2005Guerrini Genton 2004
There are certain preventive measures to avoid triggering external stimuli which are particularly useful in PSE patients but pharmacological treatment is required when seizures are not controlled by preventive measures or when photic or pattern-induced seizures coexist with spontaneous seizures However adverse effects of antiepileptic drugs AEDs and the relapse percentage after medication withdrawal which may be nearly 50 Verrotti et al 2014 drove investigators to seek other therapeutic alternatives such as the use of blue lenses that filter out red light To date the most extensively investigated lens has been Zeiss Clarlet Z1 which abolished PPRs in 759 of 610 patients Giuseppe Capovilla et al 2006 This effect was accounted for by the spectroscopic profile of Z1 that shows the minimal transmittance for the spectrum of red color 600-700 nm G Capovilla et al 1999 and a luminous transmittance for the visible spectrum τν around 7
However Z1 transmittance characteristics have two main limitations for its use in everyday life 1 it is a very dark lens and not practical in high-latitude regions where the number of sunlight hours is reduced 2 its lack of transmission in the red and yellow parts of the spectrum determines that people using Z1 are almost completely exposed to blue visible light which has been associated with the appearance of ophthalmological diseases in the long term such as age-related macular degeneration AMD blue-light hazard phenomenon Mainster 2006
2 RATIONALE
In light of these limitations we hypothesized that a new type of lenses created by improving some spectral characteristics of Z1 could also be helpful for patients with PSE This is the reason why we have designed four new lenses at the Aston Brain Center ABC Aston University in collaboration with the Aston University Vision Sciences Department These new lenses were firstly tested in those patients with PSE referred to the ABC between 2008-2017 when this center was the referral site in West Midlands to perform an EEG with photicpattern stimulation
To date no lens has demonstrated similar efficacy to Z1 with improved transmittance characteristics Our new lenses may become an alternative or adjuvant therapy for paediatric and adult patients with PSE leading to a reduction in the necessary dose of medication with consequently less probability of adverse effects and an overall improvement in the quality of life
3 AIM AND OBJECTIVES
The aim of our study is to demonstrate that our lenses are not inferior in efficacy to reduce the PPRs in comparison with Z1 in a sample of children and adolescents with PSE
1 The primary objective of this study is to investigate the efficacy of these four lenses in suppressing the PPRs evoked by IPS andor pattern stimulation in a sample of pediatric patients with PSE recruited at the Birmingham Womens and Childrens NHS Foundation Trust BWCH and compare their results with those obtained with Z1 in the same patient
2 Our secondary objectives are
To collect the retrospective information clinical and EEG data of those PSE patients who were seen between 2008 and 2017 at the ABC where the lenses were firstly tested before moving the equipment to the BWCH
To obtain feedback from the patients who finally acquire a pair of our lenses in relation to the overall adherence to treatment tolerability and improvement in the quality of life To achieve this objective we will send a patient satisfaction questionnaire PSQ to these patients approximately 6 months after purchasing the lenses
4 DESIGN
This is a single-arm clinical trial We will carry out two types of study a prospective forward study recruiting patients at BWCH and also a retrospective backwards study collecting those patients seen at the ABC between 2008 and 2017 In both studies data analysis will take place at Aston University after being pseudonymized
5 METHODS
51 Recruitment
Prospective study BWCH Aston University
Patients either males or females from 5 to 18 years with suspected or confirmed diagnosis of generalised epilepsy with photosensitivity or photosensitive epilepsy PSE who are referred to the Neurophysiology Service at BCH for an EEG with IPSpattern stimulation to confirm the diagnosis or check evolution whether they are taking AEDs or not Participants will be able to maintain concentration during the procedure follow simple commands given by the NHS PI and have the capacity to assent under 16 years or consent 16-18 years to participate after checking that they have understood the purpose of the study
Retrospective study Aston University
Selection criteria followed in the retrospective study conducted at the ABC were the same except for the age criterion since adult patients were also seen at the ABC
52 Trial Procedures
Prospective study BWCH Aston University
On the first visit to the BWCH a standardised procedure for EEG with IPS Kasteleijn-Nolst Trenité et al 2012 will be performed followed by stimulation with visual patterns stationary vertical grids at different spatial frequencies on a screen If PPRs are shown in response to IPSpattern stimulation lenses will be tested to evaluate the relative reduction produced by our lenses Z1 on the PPRs evoked by IPSpattern testing This reduction will be determined by the change in both the type of PPR and the standardized photoparoxysmal response range SPR
If our lenses are effective and patientsfamilies decide to acquire one of them they will be asked to fill in a Likert-scale PSQ approximately 6 months after purchasing the lenses This information will provide us with some feedback on the overall adherence to treatment tolerability and improvement in the quality of life
522 Retrospective study Aston University it will consist in the same procedures as the prospective study but in this case the PSQ was not sent to patientsfamilies
6 DATA ANALYSIS
A minimum sample size of 76 patients was obtained based upon data collected from a previous pilot study taking into consideration a power value of 80 an alpha value of 5 and a non-inferiority margin of 003
For each patient we will compare the reductionsuppression on both the PPR and the SPR between the different lenses α005 PSQ results will be expressed by the percentages of patientsparents who marked a particular response in these multiple-choice questionnaires
Missed data patients who finally drop out of the study will not be considered for analysis purposes
7 ETHICAL CONSIDERATIONS
All procedures conducted will comply with the Declaration of Helsinki as revised in 2013 the Data Protection Act 1998 and Local Information Governance protocols Consent will be sought from parentslegal guardians and patients over 15 years as well as assent in the case of younger patients
Only pseudonymized raw data will be available for sharing outside of the department as the analysis is to be performed by the PI-based at the sponsor site Aston University Data storage will be in keeping with the Trust Information Governance policies
Photosensitive epilepsy PSE is the most common of reflex epilepsies and represents approximately 10 of all new cases of epilepsy in the age range 7-19 years Harding Jeavons 1994 Photosensitivity is the nuclear feature of PSE in which seizures are provoked by light stimuli or visual patterns such as lines gratings or checkerboards Yalçin Kaymaz Forta 2000Fisher Harding Erba Barkley Wilkins 2005 Therefore usual external triggers of seizures in the daily life of patients with PSE are sunlight and screens like televisions TVs video games and computer displays Photicpattern sensitivity can be detected on the electroencephalogram EEG by the presence of a specific abnormality called the photoparoxysmal response PPR which is usually evoked by intermittent photic stimulation IPS or pattern stimulation respectively Quirk et al 1995 Red color wavelength around 600-700nm has been proposed to be the most provocative stimulus among the primary colors to trigger photosensitivitypattern-sensitivity in these patients Fisher et al 2005Guerrini Genton 2004
There are certain preventive measures to avoid triggering external stimuli which are particularly useful in PSE patients but pharmacological treatment is required when seizures are not controlled by preventive measures or when photic or pattern-induced seizures coexist with spontaneous seizures However adverse effects of antiepileptic drugs AEDs and the relapse percentage after medication withdrawal which may be nearly 50 Verrotti et al 2014 drove investigators to seek other therapeutic alternatives such as the use of blue lenses that filter out red light To date the most extensively investigated lens has been Zeiss Clarlet Z1 which abolished PPRs in 759 of 610 patients Giuseppe Capovilla et al 2006 This effect was accounted for by the spectroscopic profile of Z1 that shows the minimal transmittance for the spectrum of red color 600-700 nm G Capovilla et al 1999 and a luminous transmittance for the visible spectrum τν around 7
However Z1 transmittance characteristics have two main limitations for its use in everyday life 1 it is a very dark lens and not practical in high-latitude regions where the number of sunlight hours is reduced 2 its lack of transmission in the red and yellow parts of the spectrum determines that people using Z1 are almost completely exposed to blue visible light which has been associated with the appearance of ophthalmological diseases in the long term such as age-related macular degeneration AMD blue-light hazard phenomenon Mainster 2006
2 RATIONALE
In light of these limitations we hypothesized that a new type of lenses created by improving some spectral characteristics of Z1 could also be helpful for patients with PSE This is the reason why we have designed four new lenses at the Aston Brain Center ABC Aston University in collaboration with the Aston University Vision Sciences Department These new lenses were firstly tested in those patients with PSE referred to the ABC between 2008-2017 when this center was the referral site in West Midlands to perform an EEG with photicpattern stimulation
To date no lens has demonstrated similar efficacy to Z1 with improved transmittance characteristics Our new lenses may become an alternative or adjuvant therapy for paediatric and adult patients with PSE leading to a reduction in the necessary dose of medication with consequently less probability of adverse effects and an overall improvement in the quality of life
3 AIM AND OBJECTIVES
The aim of our study is to demonstrate that our lenses are not inferior in efficacy to reduce the PPRs in comparison with Z1 in a sample of children and adolescents with PSE
1 The primary objective of this study is to investigate the efficacy of these four lenses in suppressing the PPRs evoked by IPS andor pattern stimulation in a sample of pediatric patients with PSE recruited at the Birmingham Womens and Childrens NHS Foundation Trust BWCH and compare their results with those obtained with Z1 in the same patient
2 Our secondary objectives are
To collect the retrospective information clinical and EEG data of those PSE patients who were seen between 2008 and 2017 at the ABC where the lenses were firstly tested before moving the equipment to the BWCH
To obtain feedback from the patients who finally acquire a pair of our lenses in relation to the overall adherence to treatment tolerability and improvement in the quality of life To achieve this objective we will send a patient satisfaction questionnaire PSQ to these patients approximately 6 months after purchasing the lenses
4 DESIGN
This is a single-arm clinical trial We will carry out two types of study a prospective forward study recruiting patients at BWCH and also a retrospective backwards study collecting those patients seen at the ABC between 2008 and 2017 In both studies data analysis will take place at Aston University after being pseudonymized
5 METHODS
51 Recruitment
Prospective study BWCH Aston University
Patients either males or females from 5 to 18 years with suspected or confirmed diagnosis of generalised epilepsy with photosensitivity or photosensitive epilepsy PSE who are referred to the Neurophysiology Service at BCH for an EEG with IPSpattern stimulation to confirm the diagnosis or check evolution whether they are taking AEDs or not Participants will be able to maintain concentration during the procedure follow simple commands given by the NHS PI and have the capacity to assent under 16 years or consent 16-18 years to participate after checking that they have understood the purpose of the study
Retrospective study Aston University
Selection criteria followed in the retrospective study conducted at the ABC were the same except for the age criterion since adult patients were also seen at the ABC
52 Trial Procedures
Prospective study BWCH Aston University
On the first visit to the BWCH a standardised procedure for EEG with IPS Kasteleijn-Nolst Trenité et al 2012 will be performed followed by stimulation with visual patterns stationary vertical grids at different spatial frequencies on a screen If PPRs are shown in response to IPSpattern stimulation lenses will be tested to evaluate the relative reduction produced by our lenses Z1 on the PPRs evoked by IPSpattern testing This reduction will be determined by the change in both the type of PPR and the standardized photoparoxysmal response range SPR
If our lenses are effective and patientsfamilies decide to acquire one of them they will be asked to fill in a Likert-scale PSQ approximately 6 months after purchasing the lenses This information will provide us with some feedback on the overall adherence to treatment tolerability and improvement in the quality of life
522 Retrospective study Aston University it will consist in the same procedures as the prospective study but in this case the PSQ was not sent to patientsfamilies
6 DATA ANALYSIS
A minimum sample size of 76 patients was obtained based upon data collected from a previous pilot study taking into consideration a power value of 80 an alpha value of 5 and a non-inferiority margin of 003
For each patient we will compare the reductionsuppression on both the PPR and the SPR between the different lenses α005 PSQ results will be expressed by the percentages of patientsparents who marked a particular response in these multiple-choice questionnaires
Missed data patients who finally drop out of the study will not be considered for analysis purposes
7 ETHICAL CONSIDERATIONS
All procedures conducted will comply with the Declaration of Helsinki as revised in 2013 the Data Protection Act 1998 and Local Information Governance protocols Consent will be sought from parentslegal guardians and patients over 15 years as well as assent in the case of younger patients
Only pseudonymized raw data will be available for sharing outside of the department as the analysis is to be performed by the PI-based at the sponsor site Aston University Data storage will be in keeping with the Trust Information Governance policies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 266497 | OTHER | None | None |
| 20EM0030 | OTHER | REC Reference Number | None |