Lubricating Eye Drops After Routine Cataract Surgery

Cataract Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465071
• Other study ID #: 276400
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Dry Eye

Intervention

Drug:
• AEONTM Repair and AEONTM Protect Plus lubricating eye drops
AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Locations

Country	Name	City	State
United Kingdom	Guys' and St.Thomas' Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	City, University of London, King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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