GlaucomaNCT02049333
Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
A study testing Phacoemulsification and Endoscopic Cycloplasty (ECPL) in people with Glaucoma, run by Credit Valley EyeCare at 2 sites in Canada.
Trial summary
The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Phacoemulsification and Endoscopic Cycloplasty (ECPL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2010to Nov 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has to be ≥ 18 years of age of either gender
- Nuclear sclerotic cataract graded by LOCS III to be < 5
- Diagnosis of Plateau Iris Configuration or Syndrome
- No contraindication for cataract or ECPL operation
- Written informed consent on IRB approved Informed Consent Form
Who cannot join
- Hard cataracts, LOCS III 5 and 6
- Ciliary body cysts
- Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.)
- Congenital anomaly of the irido-trabecular angle
- Previous intraocular surgery
- Previous laser gonioplasty to either eye
Show all 15Show fewer
- Placement of the intraocular lens in any place other than the capsular bag
- Pupilloplasty
- Rubeosis
- Peripheral anterior synechiae (PAS) nasal angle and/or >180 degrees of PAS
- Neovascular glaucoma; or glaucoma associated with vascular ischemic disorders
- Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
- Corneal opacities or disorders that would inhibit visualization of the nasal angle
- Chronic ocular inflammatory disease or presence of active ocular inflammation with risk for synechial/proliferative changes
- Inability to attend regular follow-up assessment or to give informed written consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Osler EyeCare
Brampton, Ontario, L6V 1B4
Credit Valley EyeCare
Mississauga, Ontario, L5L 1W8
About this study
Official title: Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study
The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.
- Conditions
- Glaucoma
- Being tested
- Phacoemulsification, Endoscopic Cycloplasty (ECPL)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Endoscopic Cycloplasty (ECPL)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification | Active comparator | Cataract extraction alone Receives: Procedure: Phacoemulsification |
| Phacoemulsification with Endoscopic Cycloplasty (ECPL) | Experimental | Cataract extraction combined with endoscopic cycloplasty Receives: Procedure: Phacoemulsification; Procedure: Endoscopic Cycloplasty (ECPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Angle Depth (nasal angle)
Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging
Measured: Twelve months
Secondary outcomes (2)
Number of glaucoma medications
The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications.
Measured: Twelve months post-op
Intraocular pressure (IOP)
IOP will be recorded and compared to pre-operative IOP.
Measured: Twelve months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startNov 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Credit Valley EyeCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Iqbal Ike Ahmed, Credit Valley EyeCare
- Investigators
- Ike K Ahmed, MD FRCSC, Study director, University of Toronto, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049333
- Sponsor's protocol ID
- ECPLateau10.1
- Status last verified
- Jan 2014
- First submitted
- 27 Jan 2014
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study
- ClinicalTrials.gov ID
- NCT02049333
- Acronym / sponsor ID
- ECPLateau10.1
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Credit Valley EyeCareIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Jan 2014 (estimated)
- 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.
The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phacoemulsification | Active comparator | Procedure: PhacoemulsificationCataract extraction alone |
| Phacoemulsification with Endoscopic Cycloplasty (ECPL) | Experimental | Procedure: Phacoemulsification, Procedure: Endoscopic Cycloplasty (ECPL)Cataract extraction combined with endoscopic cycloplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has to be ≥ 18 years of age of either gender
- Nuclear sclerotic cataract graded by LOCS III to be < 5
- Diagnosis of Plateau Iris Configuration or Syndrome
- No contraindication for cataract or ECPL operation
- Written informed consent on IRB approved Informed Consent Form
Key exclusion criteria (15 listed)
- Hard cataracts, LOCS III 5 and 6
- Ciliary body cysts
- Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.)
- Congenital anomaly of the irido-trabecular angle
- Previous intraocular surgery
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 |
|---|---|---|
| Phacoemulsification | Procedure or surgery | Phacoemulsification, Phacoemulsification with Endoscopic Cycloplasty (ECPL) |
| Endoscopic Cycloplasty (ECPL) | Procedure or surgery | Phacoemulsification with Endoscopic Cycloplasty (ECPL) |
Primary outcome
Anterior Chamber Angle Depth (nasal angle)
Time frame: Twelve months
Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging
2 secondary outcomes
Number of glaucoma medications
Time frame: Twelve months post-op
Intraocular pressure (IOP)
Time frame: Twelve months post-op
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 30 Jan 2014.
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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.
Ike K Ahmed, MD FRCSC study director
University of Toronto, Toronto, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification and Endoscopic Cycloplasty (ECPL) in people with Glaucoma, run by Credit Valley EyeCare at 2 sites in Canada.
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 5 inclusion and 15 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 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
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?
Anterior Chamber Angle Depth (nasal angle) (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2014.