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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Lubricating eye drops
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
St Thomas' Hospital NHS Trust London
London, United Kingdom
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Visual Acuity
Time frame: 6 weeks
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).
Time frame: 6 weeks
Schirmer 1 test
Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency .
Time frame: 6 weeks
Tear Break up Time
Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease
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Time frame: 6 weeks
Cataract incision site and size
Assess cataract incision size in relation to other tests and symptoms.
Time frame: 6 weeks