Cataract Surgery, Dry Eye, Patient Related Outcome Measures, Patient Satisfaction
Conditions
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
Interventions
DRUGAEONTM Repair
Lubricating eye drops
OTHERRoutine post-operative eye drops used.
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
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
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction (CatPROM 5) | 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. |
| Self-reported Health Outcome | 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. |
| Patient Reported Symptoms (Speed II questinnaire) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break up Time | 6 weeks | Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease |
| Visual Acuity | 6 weeks | — |
| Cataract incision site and size | 6 weeks | Assess cataract incision size in relation to other tests and symptoms. |
| Cornea and Conjunctival Staining Scores | 6 weeks | The Oxford Scale is used to grade staining of the conjunctiva and cornea. 0-5 (0 no staining, 5 significant staining). |
| Schirmer 1 test | 6 weeks | Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency . |
Countries
United Kingdom
Contacts
Primary ContactKhayam Naderi, MBBS BSc MA
Outcome results
None listed