Clinical trial NCT04465071: Lubricating Eye Drops After Routine Cataract Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Cataract
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: City, University of London
name: King's College London
First posted: 2020-07-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The aim of this study is to investigate the routine use of such lubricating drops in a randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in the NHS setting. As these drops are provided with the intraocular lens, if found to be of benefit in reducing dry eye problems such a study might provide evidence for the universal implementa-tion of post-operative ocular lubricant drops

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

Primary outcomes:
measure: CATPROM 5 patient satisfaction score
timeFrame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
measure: EQ5D3L patient satisfaction score
timeFrame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
measure: Dry Eye Symptoms
timeFrame: Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Secondary outcomes:
measure: Visual Acuity
timeFrame: 2 week follow up and 2 month follow up
measure: Cornea and Conjunctival Staining
timeFrame: 2 week follow up and 2 month follow up
measure: Schirmer 1 Test
timeFrame: 2 week follow up and 2 month follow up
measure: Tear Break up time
timeFrame: 2 week follow up and 2 month follow up
measure: Inferior tear meniscus
timeFrame: 2 week follow up and 2 month follow up
measure: Corneal Incision site and size
timeFrame: 2 week follow up and 2 month follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys' and St.Thomas' Hospital
Study officials:
References: