Lubricating Eye Drops After Routine Cataract Surgery

Not Applicable

Completed

• Conditions: Dry Eye; Cataract
• Interventions: Drug: AEONTM Repair and AEONTM Protect Plus lubricating eye drops

• Registration Number: NCT04465071
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-02-21
• Study Start: 2020-02-24
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-09
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

1. Bilateral or unilateral cataracts requiring surgical intervention
2. Age over 18 years
3. Able to understand informed consent and the objectives of the trial
4. Not pregnant, not breast feeding
5. No previous eye surgery

Exclusion Criteria

1. age-related macula degeneration
2. glaucoma
3. previous retinal vascular disorders
4. previous retinal detachment or tear
5. any neuro-ophthalmological condition
6. any inherited retinal disorder or pathology
7. previous strabismus surgery or record of amblyopia
8. previous TIA, CVA or other vaso-occlusive disease
9. already enrolled in another study
10. already on prescribed lubricating drops

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment plus lubricating drops	AEONTM Repair and AEONTM Protect Plus lubricating eye drops	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

Primary Outcome Measures

Name	Time	Method
CATPROM 5 patient satisfaction score	Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change	Quality of life patient satisfaction questionnaire
EQ5D3L patient satisfaction score	Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change	Quality of life patient satisfaction questionnaire
Dry Eye Symptoms	Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change	Patient questionnaire SPEED II score (Maximum 28, Minimum 0)

Secondary Outcome Measures

Name	Time	Method
Cornea and Conjunctival Staining	2 week follow up and 2 month follow up	Oxford Scale (Maximum 5, minimum 0)
Corneal Incision site and size	2 week follow up and 2 month follow up	Corneal Incision site and size
Schirmer 1 Test	2 week follow up and 2 month follow up	Schirmer 1 Test (Normal \>10 mm)
Tear Break up time	2 week follow up and 2 month follow up	Non-invasive tear breakup time (normal \>10 seconds)
Inferior tear meniscus	2 week follow up and 2 month follow up	Inferior tear meniscus
Visual Acuity	2 week follow up and 2 month follow up	Logmar Visual Acuity

Trial Locations

Locations (1)

Guys' and St.Thomas' Hospital; 🇬🇧 London, United Kingdom