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

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ClinicalTrials.gov Identifier: NCT03292796
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Emily Woodhouse, Norfolk and Norwich University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Open Angle Glaucoma and Cataract Drug: Prostaglandins Phase 2

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 of glaucoma is 5% in the population over 80 years old. Thus the clinical dilemma is a common one.

A current literature search reveals that a divided opinion over whether PGAs do increase the incidence of CMO. No study has yet established a causal relationship between the use of PGAs and the development of CMO. Anecdotal reports and small case series have associated peri-operative PGA use with the occurrence of CMO (Henderson BA et al, 2007 J Cataract Refract Surg 33:1550-1558; Moroi SE et al, 1999, Ophthalmology 106:1024-1029). Whilst, in direct contrast, other authors argue CMO as a rare phenomenon and the causative relationship is debated (Schumer RA et al 2000, Curr Opin Ophthalmol 11:94-100; Miyake K et al 2003 J Cataract Refract Surg 29:1800-1810)

The most similar previous study to the one proposed, was by Miyake K et al. (Arch Ophthalmol 1999, 117:34-40). The key difference, though, is in the postoperative drop regime of fluorometholone and diclofenac in that paper and current UK clinical practice of using dexamethasone. In terms of study design, this paper used an invasive method of investigating CMO by fundus fluorescein angiography compared to OCT proposed here.

A recent case report by Agange N & Mosaed S (Journal of Ophthalmology, 2010) concludes with 'conclusions about causal relationships cannot be made without well-designed, prospective clinical trials addressing this issue'.

This study will therefore use drops that are routinely used in current UK clinical practice and add to the body of evidence that helps answer the question should PGAs be continued after cataract surgery so as to prevent the progression of glaucoma in patients.

  • Aim

    • This study investigates if the occurrence of CMO after cataract surgery is affected by the use of PGA drops by patients with glaucoma
    • The null hypothesis states there is no increase in the incidence of CMO on OCT scanning in the 4 weeks following cataract surgery whether PGA eye drops continue or are stopped.
  • Design

    • Randomised control study with parallel group design
    • Single masking of outcome assessors

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Control Trial
Masking: Single (Outcomes Assessor)
Masking Description:
  • 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
Primary Purpose: Treatment
Official Title: A Randomised Control Study to Investigate if the Continuation of Prostaglandin Analogue Treatments in the Post-operative Phase of Glaucoma Patients Undergoing Cataract Surgery Increases the Incidence of Cystoid Macular Oedema.
Actual Study Start Date : December 7, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Stop prostaglandin eye drops post op
Stop prostaglandin eye drops post operatively. Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost
Drug: Prostaglandins
Other Name: Latanoprost Travaprost Bimatoprost Tafluprost

Continue prostaglandin eye drops post op
Continue prostaglandin eye drops post operatively Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost
Drug: Prostaglandins
Other Name: Latanoprost Travaprost Bimatoprost Tafluprost




Primary Outcome Measures :
  1. Occurrence of cystoid macula oedema (CMO) at 4 weeks post operatively [ Time Frame: 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.


Secondary Outcome Measures :
  1. Intraocular pressure (IOP) at 4 weeks post-operatively. [ Time Frame: 4 weeks post operatively ]
    Intraocular pressure (IOP) at 4 weeks post-operatively. Intraocular pressure will be measured by Goldmann applanation tonometry, the standard method used in clinical practice to monitor glaucoma. This forms part of the standard post-operative examination following surgery.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292796


Contacts
Contact: Nuwan Niyadurupola, Consultant +44 1603 288373 nuwan.niyadurupola@nnuh.nhs.uk
Contact: David Broadway, Professor +44 1603 288373 david.broadway@nnuh.nhs.uk

Locations
United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Dawson Julie, Mrs    +44 1603 286611    julie.dawson@nnuh.nhs.uk   
Contact: Andrew Holmes, Mr    +44 1603 287376    andrew.holmes@nnuh.nhs.uk   
Principal Investigator: Nuwan Niyadurupola, Consultant         
Sub-Investigator: David Broadway, Professor         
Sub-Investigator: Tom Eke, Consultant         
Sponsors and Collaborators
Emily Woodhouse
Investigators
Principal Investigator: Nuwan Niyadurupola, Consultant Consultant Ophthalmologist

Publications:
Responsible Party: Emily Woodhouse, Research Grants Co-ordinator, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03292796     History of Changes
Other Study ID Numbers: 2014OPH03L(104-0614)
REC 15/EE/0239 ( Other Identifier: Research Ethics Committee )
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emily Woodhouse, Norfolk and Norwich University Hospitals NHS Foundation Trust:
Open Angle Glaucoma
Cataract
Phacoemulsification,
Cystoid Macular Oedema,
Prostaglandin Analogues

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Cataract
Macular Edema
Ocular Hypertension
Eye Diseases
Lens Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Ophthalmic Solutions
Latanoprost
Bimatoprost
Pharmaceutical Solutions
Antihypertensive Agents