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

NCT03125785 | Unknown

• 1 other identifier: saradelima1
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Cataract

Keywords

congenital cataract, contact lens

Outcome Measures

Primary Outcomes (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.

  Contact lenses will be collected and analyzed after 30 +/- 5 days of use.

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Weeks - 7 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Contact lenses from children that has undergone surgery for congenital cataract

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Erik Eye Hospital: lead

Study Officials

• Maria Kugelberg, professor

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Sara De Lima, MSc

CONTACT

+46 8 6723533; sara.delima@sll.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Optometrist, MSc

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 24, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share