Lubricating Eye Drops After Routine Cataract Surgery

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2022

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

Interventions

  • Drug: AEONTM Repair and AEONTM Protect Plus lubricating eye drops
    • AEONTM Repair and AEONTM Protect Plus lubricating eye drops

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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 Measures

  • Visual Acuity
    • Time Frame: 2 week follow up and 2 month follow up
    • Logmar Visual Acuity
  • Cornea and Conjunctival Staining
    • Time Frame: 2 week follow up and 2 month follow up
    • Oxford Scale (Maximum 5, minimum 0)
  • Schirmer 1 Test
    • Time Frame: 2 week follow up and 2 month follow up
    • Schirmer 1 Test (Normal >10 mm)
  • Tear Break up time
    • Time Frame: 2 week follow up and 2 month follow up
    • Non-invasive tear breakup time (normal >10 seconds)
  • Inferior tear meniscus
    • Time Frame: 2 week follow up and 2 month follow up
    • Inferior tear meniscus
  • Corneal Incision site and size
    • Time Frame: 2 week follow up and 2 month follow up
    • Corneal Incision site and size

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Guy’s and St Thomas’ NHS Foundation Trust
  • Collaborator
    • City, University of London
  • Provider of Information About this Clinical Study
    • Sponsor

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