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Lubricating Eye Drops After Routine Cataract Surgery

Primary Purpose

Dry Eye, Cataract

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AEONTM Repair and AEONTM Protect Plus lubricating eye drops
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guys' and St.Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Standard Treatment

Standard Treatment plus lubricating drops

Arm Description

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

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

Outcomes

Primary Outcome Measures

CATPROM 5 patient satisfaction score
Quality of life patient satisfaction questionnaire
EQ5D3L patient satisfaction score
Quality of life patient satisfaction questionnaire
Dry Eye Symptoms
Patient questionnaire SPEED II score (Maximum 28, Minimum 0)

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2020
Last Updated
September 8, 2023
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
City, University of London, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04465071
Brief Title
Lubricating Eye Drops After Routine Cataract Surgery
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
City, University of London, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Cataract

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
No masking
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment
Arm Type
No Intervention
Arm Description
Post-Cataract surgery standard treatment of Maxidex 0.1% QDS for 4 weeks, and Chloramphenicol drops QDS for 2 weeks
Arm Title
Standard Treatment plus lubricating drops
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AEONTM Repair and AEONTM Protect Plus lubricating eye drops
Intervention Description
AEONTM Repair and AEONTM Protect Plus lubricating eye drops
Primary Outcome Measure Information:
Title
CATPROM 5 patient satisfaction score
Description
Quality of life patient satisfaction questionnaire
Time Frame
Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Title
EQ5D3L patient satisfaction score
Description
Quality of life patient satisfaction questionnaire
Time Frame
Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Title
Dry Eye Symptoms
Description
Patient questionnaire SPEED II score (Maximum 28, Minimum 0)
Time Frame
Baseline, 2 week follow up and 2 month follow up. Measure scores at three times points to assess for any change
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Logmar Visual Acuity
Time Frame
2 week follow up and 2 month follow up
Title
Cornea and Conjunctival Staining
Description
Oxford Scale (Maximum 5, minimum 0)
Time Frame
2 week follow up and 2 month follow up
Title
Schirmer 1 Test
Description
Schirmer 1 Test (Normal >10 mm)
Time Frame
2 week follow up and 2 month follow up
Title
Tear Break up time
Description
Non-invasive tear breakup time (normal >10 seconds)
Time Frame
2 week follow up and 2 month follow up
Title
Inferior tear meniscus
Description
Inferior tear meniscus
Time Frame
2 week follow up and 2 month follow up
Title
Corneal Incision site and size
Description
Corneal Incision site and size
Time Frame
2 week follow up and 2 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Guys' and St.Thomas' Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Lubricating Eye Drops After Routine Cataract Surgery

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