Lubricating Eye Drops After Routine Cataract Surgery

NCT ID: NCT04465071

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2022-08-31

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

Conditions

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Dry Eye Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

No masking

Study Groups

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Standard Treatment

Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard Treatment plus lubricating 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

Group Type OTHER

AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Intervention Type DRUG

AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Interventions

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AEONTM Repair and AEONTM Protect Plus lubricating eye drops

AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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City, University of London

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guys' and St.Thomas' Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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276400

Identifier Type: -

Identifier Source: org_study_id

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