Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| City, University of London | OTHER |
| King's College London | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Experimental arm receives 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 cataract 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). |
|
| Control Arm | Active Comparator | The control arm group receive 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 after cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEONTM Repair | Drug | Lubricating eye drops |
| |
| Routine post-operative eye drops used. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | 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). | 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khayam Naderi, MBBS BSc MA | Contact | 020 7188 7188 | 84331 | khayam.naderi@gstt.nhs.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Thomas' Hospital NHS Trust London | London | SE1 7EH | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week |
|
| Schirmer 1 test | Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency . | 6 weeks |
| Tear Break up Time | Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease | 6 weeks |
| Cataract incision site and size | Assess cataract incision size in relation to other tests and symptoms. | 6 weeks |
| D001519 | Behavior |