Lubricating Eye Drops After Routine Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Patient Satisfaction,Dry Symptoms in Patients Cataract Surgery in NHS Patients Treated With Prophylactic Preservative-free Lubricant Eye Drops (AEONTM Repair, and AEONTM Protect Plus): A Randomized, Prospective, Controlled Study.

Conditions
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Dry Eye, Cataract

Intervention / Treatment
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* Drug: AEONTM Repair and AEONTM Protect Plus lubricating eye drops


Participation Criteria
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Eligibility Criteria
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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 already on prescribed lubricating drops

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Treatment<br>Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks | |
| Other: Standard Treatment plus lubricating drops<br>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 | Drug: AEONTM Repair and AEONTM Protect Plus lubricating eye drops<br>* AEONTM Repair and AEONTM Protect Plus lubricating eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |