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Completed

NCT Number: NCT04465071

Lubricating Eye Drops After Routine Cataract Surgery

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.

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Key information

Conditions

Dry Eye Cataract Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lens Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guys' and St.Thomas' Hospital

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Drug

AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Primary outcomes

  1. CATPROM 5 patient satisfaction score

    Time frame: 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

  2. EQ5D3L patient satisfaction score

    Time frame: 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

  3. Dry Eye Symptoms

    Time frame: 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 outcomes

  1. Visual Acuity

    Time frame: 2 week follow up and 2 month follow up

    Logmar Visual Acuity

  2. Cornea and Conjunctival Staining

    Time frame: 2 week follow up and 2 month follow up

    Oxford Scale (Maximum 5, minimum 0)

  3. Schirmer 1 Test

    Time frame: 2 week follow up and 2 month follow up

    Schirmer 1 Test (Normal >10 mm)

  4. Tear Break up time

    Time frame: 2 week follow up and 2 month follow up

    Non-invasive tear breakup time (normal >10 seconds)

  5. Inferior tear meniscus

    Time frame: 2 week follow up and 2 month follow up

    Inferior tear meniscus

  6. Corneal Incision site and size

    Time frame: 2 week follow up and 2 month follow up

    Corneal Incision site and size

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • City, University of London
  • King's College London

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2020
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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