- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131335
Use of Prophylactic Lubricating Drops After Cataract Surgery
October 17, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust
Patient Satisfaction and Dry Symptoms in NHS Patients Undergoing Routine Uncomplicated Cataract Surgery Treated With Prophylactic Phosphate-free, Preservative-free Lubricant Eye Drops. A Randomised Controlled Prospective Study.
This is a randomised controlled trial to assess the use of prophylactic lubricant eye-drops for 6 weeks following uncomplicated, routine cataract surgery to improve patient satisfaction and symptoms of dry eye, compared to controls.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
On entry into the study patients will be randomized to receive either 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 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) or no additional lubricant drops in addition to the usual medications described above
Study Type
Interventional
Enrollment (Anticipated)
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Khayam Naderi, MBBS BSc MA
- Phone Number: 84331 020 7188 7188
- Email: khayam.naderi@gstt.nhs.uk
Study Locations
-
-
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London, United Kingdom, SE1 7EH
- St Thomas' Hospital NHS Trust London
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Contact:
- Dr Khayam Naderi, MBBS BSc MA
- Phone Number: 84331 020 7188 7188
- Email: khayam.naderi@gstt.nhs.uk
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Principal Investigator:
- Prof David O'Brart, FRCOphth, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Bilateral or unilateral cataracts requiring surgical intervention
- 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:
- age-related macula degeneration
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
Lubricating eye drops
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
|
Active Comparator: 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.
|
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction (CatPROM 5)
Time Frame: 6 weeks
|
Validated patient satisfaction questionnaire are used.
Specially designed and validated conversion tables are used to convert raw scores from questionnaires to Rasch calibrated measures.
|
6 weeks
|
Self-reported Health Outcome
Time Frame: 6 weeks
|
A validated self-reported health questionnaire is used where a descriptive and vertical Visual Analogue Scale (VAS) are used.
The descriptive scale assesses 5 domains at three levels of difficulty (no / some / extreme problems).
The VAS is used to to record patients' self-reported health on a scale from 0-100 (100/100 being excellent health, 0/100 being very poor health.
|
6 weeks
|
Patient Reported Symptoms (Speed II questinnaire)
Time Frame: 6 weeks
|
A validated questionnaire is used with a grading system to grade severity of dry eye .
symptoms.
Score out of 28.
Higher the score, the more significant the dry eye symptoms.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity
Time Frame: 6 weeks
|
6 weeks
|
|
Cornea and Conjunctival Staining Scores
Time Frame: 6 weeks
|
The Oxford Scale is used to grade staining of the conjunctiva and cornea.
0-5 (0 no staining, 5 significant staining).
|
6 weeks
|
Schirmer 1 test
Time Frame: 6 weeks
|
Evaluation of aqueous tear production.
Score of more than 10mm is normal.
Less than 10mm indicates aqueous tear deficiency .
|
6 weeks
|
Tear Break up Time
Time Frame: 6 weeks
|
Score of more than 10 seconds is normal.
Less than 10 seconds indicates tear evaporative eye disease
|
6 weeks
|
Cataract incision site and size
Time Frame: 6 weeks
|
Assess cataract incision size in relation to other tests and symptoms.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 14, 2019
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
October 16, 2019
First Submitted That Met QC Criteria
October 17, 2019
First Posted (Actual)
October 18, 2019
Study Record Updates
Last Update Posted (Actual)
October 18, 2019
Last Update Submitted That Met QC Criteria
October 17, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 265860
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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