RCT to Investigate if Prostaglandin Analogue Drops Increase the Risk of Cystoid Macular Oedema After Cataract Surgery.

• Status: Completed
• Trial end date: 2020-07-25
• Target enrollment: 0
• Participant gender: All

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 they heal from surgery.

Prostaglandin analogues (PGA) are the commonest first line drugs used in the long-term treatment of primary open angle glaucoma (POAG)- where they reduce the pathologically high pressure in the eye. Prostaglandins are inflammatory mediators.

In the post-operative care of glaucoma patients undergoing cataract surgery, there is a clinical dilemma whether to stop or continue the use of prostaglandin eye drops. Clinical practice is completely dichotomized between continuing and stopping PGA treatment in the postoperative period. There is conflicting scientific literature on the effect of PGA on the incidence of CMO; and only a single randomized control trial (Miyake K, Arch Ophthalmol 1999, 117:34-40), where the post operative regime is not applicable to present practice, compared the incidence of CMO following routine cataract surgery in POAG on PGA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emily Woodhouse; Julie Dawson
• Treatments: Bimatoprost; Latanoprost; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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