Use of Prophylactic Lubricating Drops After Cataract Surgery

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Dry Eye; Patient Satisfaction; Patient Related Outcome Measures; Cataract Surgery

Treatments: Other: Routine post-operative eye drops used.; Drug: AEONTM Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04131335

265860

Details and patient eligibility

About

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.

Full 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

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

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).

Treatment:

Other: Routine post-operative eye drops used.

Drug: AEONTM Repair

Control Arm

Active Comparator group

Description:

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.

Treatment:

Other: Routine post-operative eye drops used.