NCT04131335

Brief Summary

This is a randomised controlled trial to assess the use of prophylactic lubricant eye-drops for 6 weeks following uncomplicated, routine cataract surgery to improve patient satisfaction and symptoms of dry eye, compared to controls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

October 16, 2019

Last Update Submit

October 17, 2019

Conditions

Dry EyeCataract SurgeryPatient Related Outcome MeasuresPatient Satisfaction

Outcome Measures

Primary Outcomes (3)

  • Patient Satisfaction (CatPROM 5)

    Validated patient satisfaction questionnaire are used. Specially designed and validated conversion tables are used to convert raw scores from questionnaires to Rasch calibrated measures.

    6 weeks

  • Self-reported Health Outcome

    A validated self-reported health questionnaire is used where a descriptive and vertical Visual Analogue Scale (VAS) are used. The descriptive scale assesses 5 domains at three levels of difficulty (no / some / extreme problems). The VAS is used to to record patients' self-reported health on a scale from 0-100 (100/100 being excellent health, 0/100 being very poor health.

    6 weeks

  • Patient Reported Symptoms (Speed II questinnaire)

    A validated questionnaire is used with a grading system to grade severity of dry eye . symptoms. Score out of 28. Higher the score, the more significant the dry eye symptoms.

    6 weeks

Secondary Outcomes (5)

  • Visual Acuity

    6 weeks

  • Cornea and Conjunctival Staining Scores

    6 weeks

  • Schirmer 1 test

    6 weeks

  • Tear Break up Time

    6 weeks

  • Cataract incision site and size

    6 weeks

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Experimental arm receives lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following cataract surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks).

Drug: AEONTM RepairOther: Routine post-operative eye drops used.

Control Arm

ACTIVE COMPARATOR

The control arm group receive the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks after cataract surgery.

Other: Routine post-operative eye drops used.

Interventions

AEONTM RepairDRUG

Lubricating eye drops

Experimental Arm
Routine post-operative eye drops used.OTHER

Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week

Control ArmExperimental Arm

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Thomas' Hospital NHS Trust London

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye SyndromesPatient Satisfaction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Khayam Naderi, MBBS BSc MA

CONTACT

020 7188 7188khayam.naderi@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

October 14, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

October 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)