Open Angle Glaucoma and CataractPhase 2CMONCT03292796
RCT to Investigate if Prostaglandin Analogue Drops Increase the Risk of Cystoid Macular Oedema After Cataract Surgery.
A Phase 2 study testing Prostaglandins in people with Open Angle Glaucoma and Cataract, run by Julie Dawson at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Open Angle Glaucoma and Cataract
- What is being tested?
- Prostaglandins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2016to 25 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
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.
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.
Read the 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
- Conditions
- Open Angle Glaucoma and Cataract
- Being tested
- Prostaglandins
- Keywords
- Open Angle Glaucoma, Cataract, Phacoemulsification,, Cystoid Macular Oedema,, Prostaglandin Analogues
- Medical subject headings
- Glaucoma, Open-Angle, Cataract, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProstaglandinsDrug
Also called Latanoprost Travaprost Bimatoprost Tafluprost
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Prostaglandins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks post operatively
Secondary outcomes (1)
Intraocular pressure (IOP) at 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.
Measured: 4 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start7 Dec 2016
- Primary completion21 Oct 2019
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Open Angle Glaucoma and CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- Nuwan Niyadurupola, Consultant, Principal investigator, Consultant Ophthalmologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292796
- Sponsor's protocol ID
- 2014OPH03L(104-0614)
- Other IDs
- REC 15/EE/0239
- Acronym
- CMO
- Status last verified
- Oct 2020
- First submitted
- 21 Sep 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21076526Henderson 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.
PubMed 17720069Miyake 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.
PubMed 9930158Miyake 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.
PubMed 14522305Moroi 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.
PubMed 10328408Schumer 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.
PubMed 10848227
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03292796
- Acronym / sponsor ID
- CMO / 2014OPH03L(104-0614)
- Conditions
- Open Angle Glaucoma and Cataract
- Keywords
- Open Angle Glaucoma, Cataract, Phacoemulsification,, Cystoid Macular Oedema,, Prostaglandin Analogues
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Stop prostaglandin eye drops post op | Other | Drug: ProstaglandinsStop prostaglandin eye drops post operatively. Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost |
| Continue prostaglandin eye drops post op | Other | Drug: ProstaglandinsContinue prostaglandin eye drops post operatively Prostaglandins either stopped or continued after cataract surgery. Latanoprost Travaprost Bimatoprost Tafluprost |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- Subjects with additional risk factors for macula oedema (eg. diabetic retinopathy, previous macula oedema, uveitis)
- Subjects with advanced glaucoma
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProstaglandinsAlso: Latanoprost Travaprost Bimatoprost Tafluprost | Drug | Continue prostaglandin eye drops post op, Stop prostaglandin eye drops post op |
Primary outcome
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.
1 secondary outcome
Intraocular pressure (IOP) at 4 weeks post-operatively.
Time frame: 4 weeks post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 21076526Agange 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.
- Background: PubMed 17720069Henderson 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.
- Background: PubMed 9930158Miyake 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.
- Background: PubMed 14522305Miyake 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.
- Background: PubMed 10328408Moroi 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.
- Background: PubMed 10848227Schumer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuwan Niyadurupola, Consultant principal investigator
Consultant Ophthalmologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostaglandins in people with Open Angle Glaucoma and Cataract, run by Julie Dawson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of cystoid macula oedema (CMO) at 4 weeks post operatively (time frame: 4 weeks post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292796, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.