Use of Prophylactic Lubricating Drops After Cataract Surgery

Sponsor

Guy's and St Thomas' NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT04131335

Collaborator

City, University of London (Other), King's College London (Other)

168

Enrollment

Location

Arms

7.6

Anticipated Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Cataract Surgery Patient Related Outcome Measures Patient Satisfaction	Drug: AEONTM Repair Other: Routine post-operative eye drops used.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Oct 14, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Arm 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).	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
Active Comparator: Control Arm 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.	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

Arm

Intervention/Treatment

Experimental: Experimental Arm

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).

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

Active Comparator: Control Arm

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.

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

Outcome Measures

Primary Outcome Measures

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

Visual Acuity [6 weeks]
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).
Schirmer 1 test [6 weeks]
Evaluation of aqueous tear production. Score of more than 10mm is normal. Less than 10mm indicates aqueous tear deficiency .
Tear Break up Time [6 weeks]
Score of more than 10 seconds is normal. Less than 10 seconds indicates tear evaporative eye disease
Cataract incision site and size [6 weeks]
Assess cataract incision size in relation to other tests and symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Thomas' Hospital NHS Trust London	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guy's and St Thomas' NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04131335

Other Study ID Numbers:

265860

First Posted:

Oct 18, 2019

Last Update Posted:

Oct 18, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Ophthalmic Solutions

Study Results

No Results Posted as of Oct 18, 2019