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The Effect of Ophthalmic Solutions on Contact Lenses Used After Surgery for Congenital Cataract Investigated in Vivo

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ClinicalTrials.gov Identifier: NCT03125785
Recruitment Status : Not yet recruiting
First Posted : April 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sara De Lima, St. Erik Eye Hospital

Brief 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 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.


Condition or disease
Congenital Cataract

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: The Effect of Ophthalmic Solutions on Contact Lenses Used After Surgery for Congenital Cataract Investigated in Vivo
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Wear

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Contact lenses from children that has undergone surgery for congenital cataract
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients that has used other eye drops in combination with the investigated drop

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125785


Contacts
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Contact: Sara De Lima, MSc +46 8 6723533 sara.delima@sll.se

Sponsors and Collaborators
St. Erik Eye Hospital
Investigators
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Study Director: Maria Kugelberg, professor Karolinska Institutet

Additional Information:

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Responsible Party: Sara De Lima, Optometrist, MSc, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT03125785     History of Changes
Other Study ID Numbers: saradelima1
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sara De Lima, St. Erik Eye Hospital:
congenital cataract, contact lens
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions