Use of Prophylactic Lubricating Drops After Cataract Surgery

Not Applicable

• Conditions: Cataract Surgery; Dry Eye; Patient Related Outcome Measures; Patient Satisfaction
• Interventions: Drug: AEONTM Repair; Other: Routine post-operative eye drops used.

• Registration Number: NCT04131335
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Detailed 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

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-14
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-17
• Study First Posted: 2019-10-18
• Last Update Posted: 2019-10-18
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	AEONTM Repair	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).
Experimental Arm	Routine post-operative eye drops used.	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).
Control Arm	Routine post-operative eye drops used.	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.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction (CatPROM 5)	6 weeks	Validated patient satisfaction questionnaire are used. Specially designed and validated conversion tables are used to convert raw scores from questionnaires to Rasch calibrated measures.
Self-reported Health Outcome	6 weeks	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.
Patient Reported Symptoms (Speed II questinnaire)	6 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St Thomas' Hospital NHS Trust London; 🇬🇧 London, United Kingdom