Lubricating Eye Drops After Routine Cataract Surgery

Sponsor

Guy's and St Thomas' NHS Foundation Trust (Other)

Overall Status

Suspended

CT.gov ID

NCT04465071

Collaborator

City, University of London (Other), King's College London (Other)

168

Enrollment

Location

Arms

17.2

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Cataract	Drug: AEONTM Repair and AEONTM Protect Plus lubricating eye drops	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 dropsTo 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

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

Feb 24, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Treatment 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 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 AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Arm

Intervention/Treatment

No Intervention: Standard Treatment

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

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

AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Outcome Measures

Primary Outcome Measures

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

Visual Acuity [2 week follow up and 2 month follow up]
Logmar Visual Acuity
Cornea and Conjunctival Staining [2 week follow up and 2 month follow up]
Oxford Scale (Maximum 5, minimum 0)
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
Corneal Incision site and size [2 week follow up and 2 month follow up]
Corneal Incision site and size

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guys' and St.Thomas' Hospital	London		United Kingdom

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guy's and St Thomas' NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04465071

Other Study ID Numbers:

276400

First Posted:

Jul 9, 2020

Last Update Posted:

Jul 9, 2020

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Ophthalmic Solutions

Lubricant Eye Drops

Study Results

No Results Posted as of Jul 9, 2020