Cataract, Dry Eye
Conditions
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
Interventions
DRUGAEONTM Repair and AEONTM Protect Plus lubricating eye drops
AEONTM Repair and AEONTM Protect Plus lubricating eye drops
Sponsors
City, University of London
King's College London
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No masking
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Quality of life patient satisfaction questionnaire |
| 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 | Quality of life patient satisfaction questionnaire |
| Dry Eye Symptoms | Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change | Patient questionnaire SPEED II score (Maximum 28, Minimum 0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break up time | 2 week follow up and 2 month follow up | Non-invasive tear breakup time (normal \>10 seconds) |
| Visual Acuity | 2 week follow up and 2 month follow up | Logmar Visual Acuity |
| Corneal Incision site and size | 2 week follow up and 2 month follow up | Corneal Incision site and size |
| Inferior tear meniscus | 2 week follow up and 2 month follow up | Inferior tear meniscus |
| Cornea and Conjunctival Staining | 2 week follow up and 2 month follow up | Oxford Scale (Maximum 5, minimum 0) |
| Schirmer 1 Test | 2 week follow up and 2 month follow up | Schirmer 1 Test (Normal \>10 mm) |
Countries
United Kingdom
Outcome results
None listed