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Clinical trial

Patient Satisfaction,Dry Symptoms in Patients Cataract Surgery in NHS Patients Treated With Prophylactic Preservative-free Lubricant Eye Drops (AEONTM Repair, and AEONTM Protect Plus): A Randomized, Prospective, Controlled Study.

ID
Name
276400
Description
Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled study.
Trial arms
Trial start
2020-02-24
Estimated PCD
2022-08-31
Trial end
2022-08-31
Status
Completed
Treatment
AEONTM Repair and AEONTM Protect Plus lubricating eye drops
AEONTM Repair and AEONTM Protect Plus lubricating eye drops
Arms:
Standard Treatment plus lubricating drops
Size
79
Primary endpoint
CATPROM 5 patient satisfaction score
Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
EQ5D3L patient satisfaction score
Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Dry Eye Symptoms
Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Eligibility criteria
Inclusion Criteria: 1. Bilateral or unilateral cataracts requiring surgical intervention 2. Age over 18 years 3. Able to understand informed consent and the objectives of the trial 4. Not pregnant, not breast feeding 5. No previous eye surgery Exclusion Criteria: 1. age-related macula degeneration 2. glaucoma 3. previous retinal vascular disorders 4. previous retinal detachment or tear 5. any neuro-ophthalmological condition 6. any inherited retinal disorder or pathology 7. previous strabismus surgery or record of amblyopia 8. previous TIA, CVA or other vaso-occlusive disease 9. already enrolled in another study 10. already on prescribed lubricating drops
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To assess the use of additional lubricant eye-drops for 6 weeks following uncomplicated, routine cataract sur-gery to improve patient satisfaction and symptoms of dry eye in an NHS (public health care) setting, compared to no additional lubricating eye drops', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}}, 'enrollmentInfo': {'count': 79, 'type': 'ACTUAL'}}
Updated at
2023-09-13

1 organization

1 product

2 indications

Organization
Guy's and St Thomas' NHS Foundation Trust
Product
AEON Repair and AEON Protect Plus
Indication
Dry Eye
Indication
Cataract