Use of Prophylactic Lubricating Drops After Cataract Surgery
NCT ID: NCT04131335
Last Updated: 2019-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
168 participants
INTERVENTIONAL
2019-10-14
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Arm
Experimental arm receives lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following cataract surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks).
AEONTM Repair
Lubricating eye drops
Routine post-operative eye drops used.
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
Control Arm
The control arm group receive the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks after cataract surgery.
Routine post-operative eye drops used.
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
Interventions
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AEONTM Repair
Lubricating eye drops
Routine post-operative eye drops used.
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years
* Able to understand informed consent and the objectives of the trial
* Not pregnant, not breast feeding
* No previous eye surgery
Exclusion Criteria
* glaucoma
* previous retinal vascular disorders
* previous retinal detachment or tear
* any neuro-ophthalmological condition
* any inherited retinal disorder or pathology
* previous strabismus surgery or record of amblyopia
* previous TIA, CVA or other vaso-occlusive disease
* already enrolled in another study
18 Years
100 Years
ALL
Yes
Sponsors
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City, University of London
OTHER
King's College London
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Locations
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St Thomas' Hospital NHS Trust London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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265860
Identifier Type: -
Identifier Source: org_study_id
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