Back to resultsUse of Prophylactic Lubricating Drops After Cataract Surgery
Primary Purpose
Dry Eye, Cataract Surgery, Patient Related Outcome Measures
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AEONTM Repair
Routine post-operative eye drops used.
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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
Sites / Locations
- St Thomas' Hospital NHS Trust London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Arm
Control Arm
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Patient Satisfaction (CatPROM 5)
Validated patient satisfaction questionnaire are used. Specially designed and validated conversion tables are used to convert raw scores from questionnaires to Rasch calibrated measures.
Self-reported Health Outcome
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.
Patient Reported Symptoms (Speed II questinnaire)
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.
Secondary Outcome Measures
Visual Acuity
Cornea and Conjunctival Staining Scores
The Oxford Scale is used to grade staining of the conjunctiva and cornea. 0-5 (0 no staining, 5 significant staining).
Schirmer 1 test
Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency .
Tear Break up Time
Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease
Cataract incision site and size
Assess cataract incision size in relation to other tests and symptoms.
Full Information
NCT ID
NCT04131335
First Posted
October 16, 2019
Last Updated
October 17, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
City, University of London, King's College London
1. Study Identification
Unique Protocol Identification Number
NCT04131335
Brief Title
Use of Prophylactic Lubricating Drops After Cataract Surgery
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
City, University of London, King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Cataract Surgery, Patient Related Outcome Measures, Patient Satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AEONTM Repair
Intervention Description
Lubricating eye drops
Intervention Type
Other
Intervention Name(s)
Routine post-operative eye drops used.
Intervention Description
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
Primary Outcome Measure Information:
Title
Patient Satisfaction (CatPROM 5)
Description
Validated patient satisfaction questionnaire are used. Specially designed and validated conversion tables are used to convert raw scores from questionnaires to Rasch calibrated measures.
Time Frame
6 weeks
Title
Self-reported Health Outcome
Description
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.
Time Frame
6 weeks
Title
Patient Reported Symptoms (Speed II questinnaire)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
6 weeks
Title
Cornea and Conjunctival Staining Scores
Description
The Oxford Scale is used to grade staining of the conjunctiva and cornea. 0-5 (0 no staining, 5 significant staining).
Time Frame
6 weeks
Title
Schirmer 1 test
Description
Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency .
Time Frame
6 weeks
Title
Tear Break up Time
Description
Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease
Time Frame
6 weeks
Title
Cataract incision site and size
Description
Assess cataract incision size in relation to other tests and symptoms.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khayam Naderi, MBBS BSc MA
Phone
020 7188 7188
Ext
84331
Email
khayam.naderi@gstt.nhs.uk
Facility Information:
Facility Name
St Thomas' Hospital NHS Trust London
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Khayam Naderi, MBBS BSc MA
Phone
020 7188 7188
Ext
84331
Email
khayam.naderi@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Prof David O'Brart, FRCOphth, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Prophylactic Lubricating Drops After Cataract Surgery
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