Status:
COMPLETED
RCT to Investigate if Prostaglandin Analogue Drops Increase the Risk of Cystoid Macular Oedema After Cataract Surgery.
Lead Sponsor:
Julie Dawson
Conditions:
Open Angle Glaucoma and Cataract
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
Post-operative cystoid macular oedema (CMO) is a common complication causing visual loss following routine cataract surgery. This complication is more prevalent in eyes with excessive inflammation as ...
Detailed Description
This study aims to answer the common clinical question of whether or not to stop PGA after routine cataract surgery. Cataract surgery is the commonest operation performed on the NHS and the prevalence...
Eligibility Criteria
Inclusion
- Primary open-angle glaucoma and ocular hypertensive subjects undergoing cataract surgery (routine phacoemulsification and intraocular lens implantation) AND on current topical glaucoma treatment with a prostaglandin analogue eye drop for at least 2 months prior to cataract surgery.
- Subjects capable of giving informed consent
Exclusion
- Subjects with additional risk factors for macula oedema (eg. diabetic retinopathy, previous macula oedema, uveitis)
- Subjects with advanced glaucoma
- Advanced visual field loss (Humphrey Mean Deviation \>-12dB)
- Advanced glaucomatous disc changes (vertical cup-to-disc ratio \>0.9)
- Subjects with non-controlled intraocular pressure (IOP) (pre-operative IOP \>22 mmHg)
- Any contra-indication to the use of topical prostaglandin drops
- Any contra-indication to the use of routine post-operative dexamethasone 0.1% eye drops
- Pregnancy
- Patients unable to give informed consent
- Intra-operative complication during cataract phacoemulsification and intraocular lens implantation
Key Trial Info
Start Date :
December 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03292796
Start Date
December 7 2016
End Date
July 25 2020
Last Update
October 8 2020
Active Locations (1)
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1
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY