Use of Prophylactic Lubricating Drops After Cataract Surgery

Dry Eye Clinical Trial

Official title:

Patient Satisfaction and Dry Symptoms in NHS Patients Undergoing Routine Uncomplicated Cataract Surgery Treated With Prophylactic Phosphate-free, Preservative-free Lubricant Eye Drops. A Randomised Controlled Prospective Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04131335
• Other study ID #: 265860
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: June 2020

Study information

• Verified date: October 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Khayam Naderi, MBBS BSc MA
• Phone: 020 7188 7188
• Email: khayam.naderi[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

On entry into the study patients will be randomized to receive either 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 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) or no additional lubricant drops in addition to the usual medications described above

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Dry Eye
• Patient Related Outcome Measures
• Patient Satisfaction

Intervention

Drug:
• AEONTM Repair
Lubricating eye drops

Other:
• Routine post-operative eye drops used.
Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital NHS Trust London	London

Sponsors (3)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Visual Acuity		6 weeks
Secondary	Cornea and Conjunctival Staining Scores	The Oxford Scale is used to grade staining of the conjunctiva and cornea. 0-5 (0 no staining, 5 significant staining).	6 weeks
Secondary	Schirmer 1 test	Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency .	6 weeks
Secondary	Tear Break up Time	Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease	6 weeks
Secondary	Cataract incision site and size	Assess cataract incision size in relation to other tests and symptoms.	6 weeks