Congenital CataractNCT03125785
The Effect of Ophthalmic Solutions on Contact Lenses Used After Surgery for Congenital Cataract Investigated in Vivo
An observational study of Congenital Cataract, run by St. Erik Eye Hospital.
Trial summary
Patients with congenital cataract operated at St. Erik Eye Hospital are given the topical steroid dexamethasone (Isopto-Maxidex) according to a set treatment plan. They are provided a contact lens made of the polymer Filcon 4A that is frequently replaced due to the results of previous in vitro studies that have shown… Read more about this study
- Who is it for?
- Ages 3 weeks to 7 years
- Conditions the study is for
- Congenital Cataract
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Dec 2019
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 weeks to 7 years
- All sexes
- Child
Study population: Contact lenses from children that has undergone surgery for congenital cataract
Who may be able to join
- Patients that has undergone surgery for congenital cataract
- Must have used contact lenses for 30 +/- days in conjunction with the surgery
- Must have followed the set treatment dexamethasone treatment plan
Who cannot join
- Patients that has used other eye drops in combination with the investigated drop
Trial locations and contacts
No sites are listed yet.
About this study
Patients with congenital cataract operated at St. Erik Eye Hospital are given the topical steroid dexamethasone (Isopto-Maxidex) according to a set treatment plan. They are provided a contact lens made of the polymer Filcon 4A that is frequently replaced due to the results of previous in vitro studies that have shown accumulation of preservatives in the hydrogel contact lens matrix which could question their use in combination with ophthalmic solutions. We conducted a pilot study that indicate that the results in vivo are different from the results in vitro and we suspect that insignificant amounts of dexamethasone and benzalkonium chloride are taken up by the lenses due to tear drainage.
Contact lenses from 30 patients at St. Erik Hospital that have undergone surgery for congenital cataract and are treated with eye drops containing dexamethasone and benzalkonium chloride will be collected and analyzed. Ultraviolet-Visible spectrophotometer (UV-vis) and Laser desorption ionization-mass spectrometry (LDI-MS) will be used to study uptake and release of dexamethasone and benzalkonium chloride. Scanning electron microscopy (SEM) will be used to study surface morphology. Thirty Contact lenses from a control group without topical treatment will also be analyzed. Data will consist of contact lens material, wearing time, pharmaceutical agents, contact lens solution when applicable, diagnosis and possible co-morbidity.
Read the detailed description
Contact lenses are frequently used as a part of the treatment in professional hospital eye care with indications such as visual aid in keratokonus and scarred corneas and as bandage lenses shielding the cornea in various corneal diseases. An indication of great importance is the providing the visual correction in infants following surgery for congenital cataract. In Sweden, approximately 40 children are born with congenital cataract every year and more than 100 children develop cataract within the first years of life. The cataract can develop in one eye, unilateral cataract, or in both eyes, bilateral cataract. If the cataract is dense it is of great importance to remove the clouded lens as soon as possible to ensure the influx of light and to enable visual development. If the eye is big enough an intraocular lens (IOL) is inserted but if the eye is to small the child is left without an implanted lens. Visual development however requires not only light influx but a sharp image on the retina and to achieve good visual function contact lenses are fitted following surgery. After cataract surgery anti-inflammatory eye drops containing steroids are prescribed for several weeks and the drops are instilled in the eye with the contact lens in place.The effects of eye drops on the contact lenses and possible secondary effects on the eye are largely unknown. The ophthalmic solutions contain active ingredients as well as preservatives such as benzalkonium chloride. Benzalkonium chloride can increase the ocular permeability but also cause irritation at higher concentrations. The uptake of these substances by the lenses can impair the optical clarity of the lenses, cause discoloration, discomfort and irritate the eye. Some studies have shown accumulation of preservatives in the hydrogel contact lens matrix which could question their use in combination with ophthalmic solutions and have led to recommendations of frequent replacement of the lenses. The effects of ophthalmic solutions on the lens materials are not fully understood and most studies are performed in vitro. In collaboration with the Royal Institute of Technology (KTH) methods for measuring drug and preservative uptake by silicone hydrogel contact lenses and to study the surface morphology changes for contact lenses were developed. An in vitro model study showed that active ingredients from eye drops together with preservatives were taken up by the lenses in significant amounts. The method was further implemented in an in vivo pilot study with contact lenses collected from patients treated with different ophthalmologic preparations with the contact lens in place. No traces of active ingredients or preservatives could be found on the worn and treated lenses. The surface morphology changes were minor regardless of the time the lenses were worn or the frequency of medication, which suggests that insignificant amounts of drugs were taken up and the drugs were probably mostly removed by tear drainage. The results are presented in a manuscript that will be sent for publication.
- Conditions
- Congenital Cataract
- Keywords
- congenital cataract, contact lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| contact lens and eye drops | Contact lenses collected from patients that have used eye drops containing dexamethasone and benzalkonium chloride for a set period of time and set dosage after surgery | |
| contact lens and no eye drops | Contact lenses used for the same period of time collected from a control group that has had no surgery and no eye drops in combination with their contact lenses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake or no uptake of dexamethasone and/or benzalkonium chloride in used contact lenses.
Contact lenses from patients at St. Erik Eye Hospital that have undergone surgery for congenital cataract and are treated with eye drops containing dexamethasone and benzalkonium chloride will be collected and analyzed. Ultraviolet-Visible spectrophotometer (UV-vis) and Laser desorption ionization-mass spectrometry (LDI-MS) will be used to study uptake and release of dexamthasone and benzalkonium chloride. Scanning electron microscopy (SEM) will be used to study surface morphology. Contact lenses from a control group that has had no surgery and therefore no topical treatment will also be analyzed.
Measured: Contact lenses will be collected and analyzed after 30 +/- 5 days of use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- St. Erik Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara De Lima, St. Erik Eye Hospital
- Investigators
- Maria Kugelberg, professor, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125785
- Sponsor's protocol ID
- saradelima1
- Status last verified
- May 2017
- First submitted
- 11 Apr 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ophthalmic Solutions on Contact Lenses Used After Surgery for Congenital Cataract Investigated in Vivo
- ClinicalTrials.gov ID
- NCT03125785
- Acronym / sponsor ID
- saradelima1
- Conditions
- Congenital Cataract
- Keywords
- congenital cataract, contact lens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. Erik Eye HospitalUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with congenital cataract operated at St. Erik Eye Hospital are given the topical steroid dexamethasone (Isopto-Maxidex) according to a set treatment plan. They are provided a contact lens made of the polymer Filcon 4A that is frequently replaced due to the results of previous in vitro studies that have shown accumulation of preservatives in the hydrogel contact lens matrix which could question their use in combination with ophthalmic solutions. We conducted a pilot study that indicate that the results in vivo are different from the results in vitro and we suspect that insignificant amounts of dexamethasone and benzalkonium chloride are taken up by the lenses due to tear drainage.
Contact lenses from 30 patients at St. Erik Hospital that have undergone surgery for congenital cataract and are treated with eye drops containing dexamethasone and benzalkonium chloride will be collected and analyzed. Ultraviolet-Visible spectrophotometer (UV-vis) and Laser desorption ionization-mass spectrometry (LDI-MS) will be used to study uptake and release of dexamethasone and benzalkonium chloride. Scanning electron microscopy (SEM) will be used to study surface morphology. Thirty Contact lenses from a control group without topical treatment will also be analyzed. Data will consist of contact lens material, wearing time, pharmaceutical agents, contact lens solution when applicable, diagnosis and possible co-morbidity.
Detailed description
Contact lenses are frequently used as a part of the treatment in professional hospital eye care with indications such as visual aid in keratokonus and scarred corneas and as bandage lenses shielding the cornea in various corneal diseases. An indication of great importance is the providing the visual correction in infants following surgery for congenital cataract. In Sweden, approximately 40 children are born with congenital cataract every year and more than 100 children develop cataract within the first years of life. The cataract can develop in one eye, unilateral cataract, or in both eyes, bilateral cataract. If the cataract is dense it is of great importance to remove the clouded lens as soon as possible to ensure the influx of light and to enable visual development. If the eye is big enough an intraocular lens (IOL) is inserted but if the eye is to small the child is left without an implanted lens. Visual development however requires not only light influx but a sharp image on the retina and to achieve good visual function contact lenses are fitted following surgery. After cataract surgery anti-inflammatory eye drops containing steroids are prescribed for several weeks and the drops are instilled in the eye with the contact lens in place.The effects of eye drops on the contact lenses and possible secondary effects on the eye are largely unknown. The ophthalmic solutions contain active ingredients as well as preservatives such as benzalkonium chloride. Benzalkonium chloride can increase the ocular permeability but also cause irritation at higher concentrations. The uptake of these substances by the lenses can impair the optical clarity of the lenses, cause discoloration, discomfort and irritate the eye. Some studies have shown accumulation of preservatives in the hydrogel contact lens matrix which could question their use in combination with ophthalmic solutions and have led to recommendations of frequent replacement of the lenses. The effects of ophthalmic solutions on the lens materials are not fully understood and most studies are performed in vitro. In collaboration with the Royal Institute of Technology (KTH) methods for measuring drug and preservative uptake by silicone hydrogel contact lenses and to study the surface morphology changes for contact lenses were developed. An in vitro model study showed that active ingredients from eye drops together with preservatives were taken up by the lenses in significant amounts. The method was further implemented in an in vivo pilot study with contact lenses collected from patients treated with different ophthalmologic preparations with the contact lens in place. No traces of active ingredients or preservatives could be found on the worn and treated lenses. The surface morphology changes were minor regardless of the time the lenses were worn or the frequency of medication, which suggests that insignificant amounts of drugs were taken up and the drugs were probably mostly removed by tear drainage. The results are presented in a manuscript that will be sent for publication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contact lens and eye drops | – | –Contact lenses collected from patients that have used eye drops containing dexamethasone and benzalkonium chloride for a set period of time and set dosage after surgery |
| contact lens and no eye drops | – | –Contact lenses used for the same period of time collected from a control group that has had no surgery and no eye drops in combination with their contact lenses. |
Who may qualify
- Ages
- 3 weeks to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Contact lenses from children that has undergone surgery for congenital cataract
Key inclusion criteria (3 listed)
- Patients that has undergone surgery for congenital cataract
- Must have used contact lenses for 30 +/- days in conjunction with the surgery
- Must have followed the set treatment dexamethasone treatment plan
Key exclusion criteria (1 listed)
- Patients that has used other eye drops in combination with the investigated drop
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uptake or no uptake of dexamethasone and/or benzalkonium chloride in used contact lenses.
Time frame: Contact lenses will be collected and analyzed after 30 +/- 5 days of use.
Contact lenses from patients at St. Erik Eye Hospital that have undergone surgery for congenital cataract and are treated with eye drops containing dexamethasone and benzalkonium chloride will be collected and analyzed. Ultraviolet-Visible spectrophotometer (UV-vis) and Laser desorption ionization-mass spectrometry (LDI-MS) will be used to study uptake and release of dexamthasone and benzalkonium chloride. Scanning electron microscopy (SEM) will be used to study surface morphology. Contact lenses from a control group that has had no surgery and therefore no topical treatment will also be analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Kugelberg, professor study director
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cataract, run by St. Erik Eye Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara De Lima, MSc (+46 8 6723533, sara.delima@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake or no uptake of dexamethasone and/or benzalkonium chloride in used contact lenses. (time frame: Contact lenses will be collected and analyzed after 30 +/- 5 days of use.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.