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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Sara De Lima, MSc contact

+46 8 6723533

sara.delima@sll.se

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.

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 groups in NCT03125785
Study groupRoleWhat they receive
contact lens and eye dropsContact 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 dropsContact 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.

  1. 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.

  1. First posted24 Apr 2017
  2. Study startJun 2017 (estimated)
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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
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

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.

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