Glaucoma, Narrow AngleNCT01417858
Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs
A study testing YAG laser peripheral iridotomy in people with Glaucoma, Narrow Angle, run by Universidade Federal do Paraná at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the intra-ocular (IOP) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Narrow Angle
- What is being tested?
- YAG laser peripheral iridotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2010to Jul 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy
Who cannot join
- previous cataract surgery
Trial locations and contacts
1 site in 1 country.
Dayane Issaho, MD contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Parana
Curitiba, Paraná, 80060-150
Lucas Shiokawa
Lisandro Sakata
About this study
Official title: Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%
The purpose of this study is to compare the intra-ocular (IOP) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).
Read the detailed description
Postoperative IOP elevation is one of the most common complications after LPI.Previous studies showed that brimonidine 0.2% is effective in blunting IOP spikes after LPI.This prospective randomized double-masked interventional study will include patients with bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy.Pilocarpine 1% will be used in both eyes, and 30 minutes later, brimonidine 0.1% randomly used in one eye and brimonidine 0.2% in the contra-lateral eye. LPI with Nd:YAG laser is performed 30 minutes later in both eyes by a single glaucoma specialist. IOP measurements are assessed before the use of any eyedrop (basal IOP), 30 minutes after pilocarpine (pre-brimonidine), and 30, 60, 120, 180 minutes after LPI. Pachymetry, ultrasonic biometry, gonioscopy, and total YAG laser energy are recorded. Non-parametric test will be used for analysis.
- Conditions
- Glaucoma, Narrow Angle
- Being tested
- YAG laser peripheral iridotomy
- Keywords
- intra-ocular pressure, iridectomy, gonioscopy, ocular tonometry
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YAG laser peripheral iridotomyProcedure or surgery
Also called Alphagan
1 drop 30 minutes before yag laser iridotomy
YAG laser peripheral iridotomyProcedure or surgery
Also called Alphagan z
1 drop 30 minutes before yag laser iridotomy
| Study group | Role | What they receive |
|---|---|---|
| brimonidine 0.2% | Active comparator | Not described Receives: Procedure: YAG laser peripheral iridotomy |
| brimonidine 0.1% | Active comparator | Not described Receives: Procedure: YAG laser peripheral iridotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-ocular pressure increase
mean intra-ocular pressure increase after laser peripheral iridotomy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Narrow AngleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Investigators
- Lucas Shiokawa, MD, Principal investigator, Universidade Federal do Parana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417858
- Sponsor's protocol ID
- 0299.0.208.000-10
- Other IDs
- 2376.270/2010-11
- Status last verified
- Jun 2011
- First submitted
- 15 Aug 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brazier DJ. Neodymium-YAG laser iridotomy. J R Soc Med. 1986 Nov;79(11):658-60. doi: 10.1177/014107688607901115.
PubMed 3795210Chen TC, Ang RT, Grosskreutz CL, Pasquale LR, Fan JT. Brimonidine 0.2% versus apraclonidine 0.5% for prevention of intraocular pressure elevations after anterior segment laser surgery. Ophthalmology. 2001 Jun;108(6):1033-8. doi: 10.1016/s0161-6420(01)00545-0.
PubMed 11382625Chen TC. Brimonidine 0.15% versus apraclonidine 0.5% for prevention of intraocular pressure elevation after anterior segment laser surgery. J Cataract Refract Surg. 2005 Sep;31(9):1707-12. doi: 10.1016/j.jcrs.2005.02.035.
PubMed 16246772Drake MV. Neodymium:YAG laser iridotomy. Surv Ophthalmol. 1987 Nov-Dec;32(3):171-7. doi: 10.1016/0039-6257(87)90092-0.
PubMed 3328316Hartenbaum D, Wilson H, Maloney S, Vacarelli L, Orillac R, Sharpe E. A randomized study of dorzolamide in the prevention of elevated intraocular pressure after anterior segment laser surgery. Dorzolamide Laser Study Group. J Glaucoma. 1999 Aug;8(4):273-5.
PubMed 10464738Kashiwagi K, Abe K, Tsukahara S. Quantitative evaluation of changes in anterior segment biometry by peripheral laser iridotomy using newly developed scanning peripheral anterior chamber depth analyser. Br J Ophthalmol. 2004 Aug;88(8):1036-41. doi: 10.1136/bjo.2003.036715.
PubMed 15258021Khodadoust AA, Arkfeld DF, Caprioli J, Sears ML. Ocular effect of neodymium-YAG laser. Am J Ophthalmol. 1984 Aug 15;98(2):144-52. doi: 10.1016/0002-9394(87)90348-5.
PubMed 6548087Robin AL, Arkell S, Gilbert SM, Goossens AA, Werner RP, Korshin OM. Q-switched neodymium-YAG laser iridotomy. A field trial with a portable laser system. Arch Ophthalmol. 1986 Apr;104(4):526-30. doi: 10.1001/archopht.1986.01050160082017.
PubMed 3513746Schrems W, Eichelbronner O, Krieglstein GK. The immediate IOP response of Nd-YAG-laser iridotomy and its prophylactic treatability. Acta Ophthalmol (Copenh). 1984 Oct;62(5):673-80. doi: 10.1111/j.1755-3768.1984.tb05794.x.
PubMed 6548856Wetzel W. Ocular aqueous humor dynamics after photodisruptive laser surgery procedures. Ophthalmic Surg. 1994 May;25(5):298-302.
PubMed 8058261
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%
- ClinicalTrials.gov ID
- NCT01417858
- Acronym / sponsor ID
- 0299.0.208.000-10
- Conditions
- Glaucoma, Narrow Angle
- Keywords
- intra-ocular pressure, iridectomy, gonioscopy, ocular tonometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 16 Aug 2011 (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 compare the intra-ocular (IOP) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).
Detailed description
Postoperative IOP elevation is one of the most common complications after LPI.Previous studies showed that brimonidine 0.2% is effective in blunting IOP spikes after LPI.This prospective randomized double-masked interventional study will include patients with bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy.Pilocarpine 1% will be used in both eyes, and 30 minutes later, brimonidine 0.1% randomly used in one eye and brimonidine 0.2% in the contra-lateral eye. LPI with Nd:YAG laser is performed 30 minutes later in both eyes by a single glaucoma specialist. IOP measurements are assessed before the use of any eyedrop (basal IOP), 30 minutes after pilocarpine (pre-brimonidine), and 30, 60, 120, 180 minutes after LPI. Pachymetry, ultrasonic biometry, gonioscopy, and total YAG laser energy are recorded. Non-parametric test will be used for analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brimonidine 0.2% | Active comparator | Procedure: YAG laser peripheral iridotomy |
| brimonidine 0.1% | Active comparator | Procedure: YAG laser peripheral iridotomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy
Key exclusion criteria (1 listed)
- previous cataract 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 |
|---|---|---|
| YAG laser peripheral iridotomyAlso: Alphagan1 drop 30 minutes before yag laser iridotomy | Procedure or surgery | brimonidine 0.2% |
| YAG laser peripheral iridotomyAlso: Alphagan z1 drop 30 minutes before yag laser iridotomy | Procedure or surgery | brimonidine 0.1% |
Primary outcome
intra-ocular pressure increase
Time frame: one year
mean intra-ocular pressure increase after laser peripheral iridotomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
- Background: PubMed 3795210Brazier DJ. Neodymium-YAG laser iridotomy. J R Soc Med. 1986 Nov;79(11):658-60. doi: 10.1177/014107688607901115.
- Background: PubMed 11382625Chen TC, Ang RT, Grosskreutz CL, Pasquale LR, Fan JT. Brimonidine 0.2% versus apraclonidine 0.5% for prevention of intraocular pressure elevations after anterior segment laser surgery. Ophthalmology. 2001 Jun;108(6):1033-8. doi: 10.1016/s0161-6420(01)00545-0.
- Background: PubMed 16246772Chen TC. Brimonidine 0.15% versus apraclonidine 0.5% for prevention of intraocular pressure elevation after anterior segment laser surgery. J Cataract Refract Surg. 2005 Sep;31(9):1707-12. doi: 10.1016/j.jcrs.2005.02.035.
- Background: PubMed 3328316Drake MV. Neodymium:YAG laser iridotomy. Surv Ophthalmol. 1987 Nov-Dec;32(3):171-7. doi: 10.1016/0039-6257(87)90092-0.
- Background: PubMed 10464738Hartenbaum D, Wilson H, Maloney S, Vacarelli L, Orillac R, Sharpe E. A randomized study of dorzolamide in the prevention of elevated intraocular pressure after anterior segment laser surgery. Dorzolamide Laser Study Group. J Glaucoma. 1999 Aug;8(4):273-5.
- Background: PubMed 15258021Kashiwagi K, Abe K, Tsukahara S. Quantitative evaluation of changes in anterior segment biometry by peripheral laser iridotomy using newly developed scanning peripheral anterior chamber depth analyser. Br J Ophthalmol. 2004 Aug;88(8):1036-41. doi: 10.1136/bjo.2003.036715.
- Background: PubMed 6548087Khodadoust AA, Arkfeld DF, Caprioli J, Sears ML. Ocular effect of neodymium-YAG laser. Am J Ophthalmol. 1984 Aug 15;98(2):144-52. doi: 10.1016/0002-9394(87)90348-5.
- Background: PubMed 3513746Robin AL, Arkell S, Gilbert SM, Goossens AA, Werner RP, Korshin OM. Q-switched neodymium-YAG laser iridotomy. A field trial with a portable laser system. Arch Ophthalmol. 1986 Apr;104(4):526-30. doi: 10.1001/archopht.1986.01050160082017.
- Background: PubMed 6548856Schrems W, Eichelbronner O, Krieglstein GK. The immediate IOP response of Nd-YAG-laser iridotomy and its prophylactic treatability. Acta Ophthalmol (Copenh). 1984 Oct;62(5):673-80. doi: 10.1111/j.1755-3768.1984.tb05794.x.
- Background: PubMed 8058261Wetzel W. Ocular aqueous humor dynamics after photodisruptive laser surgery procedures. Ophthalmic Surg. 1994 May;25(5):298-302.
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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.
Dayane Issaho, MD contact
Lucas Shiokawa, MD principal investigator
Universidade Federal do Parana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YAG laser peripheral iridotomy in people with Glaucoma, Narrow Angle, run by Universidade Federal do Paraná at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2011. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas Shiokawa, MD (55 41 91432398, lucasshiokawa@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-ocular pressure increase (time frame: one year). 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 NCT01417858, which also lists 10 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 16 Aug 2011.