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| Name | Class |
|---|---|
| City, University of London | OTHER |
| King's College London | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | No Intervention | Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks | |
| Standard Treatment plus lubricating drops | Other | Lubricant eye-drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vita-mins A and E (AEONTM Repair) for 6 weeks post-Cataract surgery, in addition to the standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEONTM Repair and AEONTM Protect Plus lubricating eye drops | Drug | AEONTM Repair and AEONTM Protect Plus lubricating eye drops |
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| Measure | Description | Time Frame |
|---|---|---|
| CATPROM 5 patient satisfaction score | Quality of life patient satisfaction questionnaire | Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change |
| EQ5D3L patient satisfaction score | Quality of life patient satisfaction questionnaire | Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change |
| Dry Eye Symptoms | Patient questionnaire SPEED II score (Maximum 28, Minimum 0) | Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Logmar Visual Acuity | 2 week follow up and 2 month follow up |
| Cornea and Conjunctival Staining | Oxford Scale (Maximum 5, minimum 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys' and St.Thomas' Hospital | London | United Kingdom |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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
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No masking
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| 2 week follow up and 2 month follow up |
| Schirmer 1 Test | Schirmer 1 Test (Normal >10 mm) | 2 week follow up and 2 month follow up |
| Tear Break up time | Non-invasive tear breakup time (normal >10 seconds) | 2 week follow up and 2 month follow up |
| Inferior tear meniscus | Inferior tear meniscus | 2 week follow up and 2 month follow up |
| Corneal Incision site and size | Corneal Incision site and size | 2 week follow up and 2 month follow up |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |