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

NCT03292796 | Completed Phase 2

• 2 other identifiers: 2014OPH03L(104-0614)REC 15/EE/0239
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Open Angle Glaucoma and Cataract

Keywords

Open Angle Glaucoma; Cataract; Phacoemulsification,; Cystoid Macular Oedema,; Prostaglandin Analogues

Outcome Measures

Primary Outcomes (1)

• Occurrence of cystoid macula oedema (CMO) at 4 weeks post operatively

  Occurrence of cystoid macula oedema (CMO) at 4 weeks post operatively.Cystoid macular oedema will be defined as an increase in the central macula thickness on the OCT with characteristic intraretinal changes in the 4 weeks following surgery.

  4 weeks post operatively

Secondary Outcomes (1)

• Intraocular pressure (IOP) at 4 weeks post-operatively.

  4 weeks post operatively

Study Arms (2)

Stop prostaglandin eye drops post op

OTHER

Stop prostaglandin eye drops post operatively. Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost

Drug: Prostaglandins

Continue prostaglandin eye drops post op

OTHER

Continue prostaglandin eye drops post operatively Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost

Drug: Prostaglandins

Interventions

Prostaglandins DRUG

Also known as: Latanoprost Travaprost Bimatoprost Tafluprost

Continue prostaglandin eye drops post op; Stop prostaglandin eye drops post op

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Julie Dawson: lead

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (6)

• Agange N, Mosaed S. Prostaglandin-induced cystoid macular edema following routine cataract extraction. J Ophthalmol. 2010;2010:690707. doi: 10.1155/2010/690707. Epub 2010 Nov 7.

  PMID: 21076526 BACKGROUND

• Henderson BA, Kim JY, Ament CS, Ferrufino-Ponce ZK, Grabowska A, Cremers SL. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007 Sep;33(9):1550-8. doi: 10.1016/j.jcrs.2007.05.013.

  PMID: 17720069 BACKGROUND

• Miyake K, Ota I, Maekubo K, Ichihashi S, Miyake S. Latanoprost accelerates disruption of the blood-aqueous barrier and the incidence of angiographic cystoid macular edema in early postoperative pseudophakias. Arch Ophthalmol. 1999 Jan;117(1):34-40. doi: 10.1001/archopht.117.1.34.

  PMID: 9930158 BACKGROUND

• Miyake K, Ibaraki N, Goto Y, Oogiya S, Ishigaki J, Ota I, Miyake S. ESCRS Binkhorst lecture 2002: Pseudophakic preservative maculopathy. J Cataract Refract Surg. 2003 Sep;29(9):1800-10. doi: 10.1016/s0886-3350(03)00560-1.

  PMID: 14522305 BACKGROUND

• Moroi SE, Gottfredsdottir MS, Schteingart MT, Elner SG, Lee CM, Schertzer RM, Abrams GW, Johnson MW. Cystoid macular edema associated with latanoprost therapy in a case series of patients with glaucoma and ocular hypertension. Ophthalmology. 1999 May;106(5):1024-9. doi: 10.1016/S0161-6420(99)00528-X.

  PMID: 10328408 BACKGROUND

• Schumer RA, Camras CB, Mandahl AK. Latanoprost and cystoid macular edema: is there a causal relation? Curr Opin Ophthalmol. 2000 Apr;11(2):94-100. doi: 10.1097/00055735-200004000-00005.

  PMID: 10848227 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract; Macular Edema

Interventions

Prostaglandins

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Nuwan Niyadurupola, Consultant

  Consultant Ophthalmologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * The patient is not masked as to treatment group and are aware of whether they are to continue or stop the PGA drops * The care providers are not masked as to treatment group * Outcome assessors are masked as to the patient's treatment group for their analysis of the OCT scans over the 4 week peri-operative period. * The scans are recorded with only the randomised identifier. * This is to reduce bias in the analysis of the scans * Unmasking of each patient will occur after their analysis of their week 4 OCT scan
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Services Manager

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: December 7, 2016
• Primary Completion: October 21, 2019
• Study Completion: July 25, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

GB (1)