NCT04465071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

February 21, 2020

Last Update Submit

September 8, 2023

Conditions

Dry EyeCataract

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (6)

  • Visual Acuity

    2 week follow up and 2 month follow up

  • Cornea and Conjunctival Staining

    2 week follow up and 2 month follow up

  • Schirmer 1 Test

    2 week follow up and 2 month follow up

  • Tear Break up time

    2 week follow up and 2 month follow up

  • Inferior tear meniscus

    2 week follow up and 2 month follow up

  • +1 more secondary outcomes

Study Arms (2)

Standard Treatment

NO INTERVENTION

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

Standard Treatment plus lubricating drops

OTHER

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

Interventions

AEONTM Repair and AEONTM Protect Plus lubricating eye dropsDRUG

AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Standard Treatment plus lubricating drops

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys' and St.Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye SyndromesCataract

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

July 9, 2020

Study Start

February 24, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)