Open Angle GlaucomaNCT02868502
Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma
An observational study of Open Angle Glaucoma, run by Meir Medical Center.
Trial summary
The purpose of this study is to investigate the effect of trabeculectomy, glaucoma drainage devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP elevation with postural change from the sitting to supine positions in eyes with open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Goldmann tonometer, Pneumatonometer and Tonopen XL
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2017
- Phase
- Observational
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects with open angle glaucoma with past ocular history of surgical treatment (trabeculectomy, implantation of an Ahmed glaucoma drainage device or cyclophotocoagulation) or are using ocular hypotensive eye drops and subjects with ocular hypertension.
Who may be able to join
- OAG patients
- Ocular Hypertension (OHT) patients
- Healthy subjects, without any ocular pathology (except for refraction errors, past cataract surgery, strabismus or amblyopia).
Who cannot join
- Other intraocular surgeries within the past 3 months
- Illness effecting episcleral venous pressure, such as superior vena cava syndrome, thyroid eye disease, orbital masses
- Patients who are unable to maintain supine position for 15 minutes
- Corneal abnormalities: epithelial pathologies, corneal infection, corneal erosions, corneal scars, keratoconus, S/P corneal transplantation (lamellar/full thickness)
- Hypersensitivity to oxybuprocaine hydrochloride
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Trabeculectomy, Glaucoma Drainage Device, Cyclophotocoagulation, and Ocular Hypotensive Eye-drops on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma
The purpose of this study is to investigate the effect of trabeculectomy, glaucoma drainage devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP elevation with postural change from the sitting to supine positions in eyes with open-angle glaucoma.
Patients will be assigned to the different study groups according to their past ocular history. Interventions are similar to all study group and no medical therapy alteration will be made.
Read the detailed description
Visual impairment and blindness due to chronic progressive optic neuropathy developing from glaucoma are major health problems worldwide.
Glaucoma is a progressive, potentially blinding disease, in which the only modifiable risk factor in intraocular pressure. In a significant proportion of patients, the disease progresses despite apparent IOP control(1-3).
One factor which may explain some of this discrepancy is a fluctuation of the IOP during the day, which may be missed in a single visit to the ophthalmologist(4). Although this fluctuation depends to some degree on daily biologic rhythms and the specific type of glaucoma, a constant significant factor responsible for this effect is the IOP-dependent changes of body posture, from sitting or standing to lying down(5). Older studies have shown IOP postural changes in the range of 4-6 mmHg(6-8). Seeing how a typical patient may spend as much as a third of his life in the supine position, knowledge of IOP in this position, and its control, are of great importance in decreasing the chance for irreversible optic nerve damage.
Several studies of Liu JH(9-11) have investigated the effect of hypotensive drops on nocturnal IOP. While prostaglandin analogues (PGA) and carbonic anhydrase inhibitors (CAI) seemed to have a significant nocturnal IOP lowering effect, the effect seen with beta blockers and alpha agonists was minimal. Mansouri et al.(12) recently showed that PGA seem to flatten the IOP-related increase when moving from the sitting to the supine position at nocturnal period, without effecting other circadian IOP-related patterns.
Hirooka Kazuyuki investigated the effect of trabeculectomy on the IOP fluctuations caused by postural changes(13-14). He showed that successful trabeculectomy, which didn't require needling, have significantly decreased the posture-induced IOP changes to less than 3 mmHg.
To the best of our knowledge there is no data regarding the effect of glaucoma drainage devices and cyclophotocoagulation on supine IOP.
The purpose of this study is to investigate the effect of different IOP lowering methods, including trabeculectomy, glaucoma drainage devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP with postural change from the sitting to supine positions in eyes with open-angle glaucoma.
- Conditions
- Open Angle Glaucoma
- Being tested
- Goldmann tonometer, Pneumatonometer, Tonopen XL, ICare rebound tonometer
- Keywords
- Glaucoma, Open Angle Glaucoma, Intra Ocular Pressure, Ocular Hypotensive Drops, Trabeculectomy, Cyclophotocoagulation, Glaucoma Drainage Device
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goldmann tonometerDevice
IOP measurement in the sitting position and lateral decubitus
PneumatonometerDevice
IOP measurement in the sitting position and lateral decubitus
Tonopen XLDevice
IOP measurement in the sitting position and lateral decubitus
ICare rebound tonometerDevice
IOP measurement in the sitting position and lateral decubitus
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy | Subjects with OAG s/p Trabeculectomy. IOP measurement in different positions. Receives: Device: Goldmann tonometer; Device: Pneumatonometer; Device: Tonopen XL; Device: ICare rebound tonometer | |
| Ahmed Glaucoma Valve implantation | Subjects with OAG s/p Ahmed valve implantation. IOP measurement in different positions. Receives: Device: Goldmann tonometer; Device: Pneumatonometer; Device: Tonopen XL; Device: ICare rebound tonometer | |
| Cyclophotocoagulation | Subjects with OAG s/p Cyclophotocoagulation. IOP measurement in different positions. Receives: Device: Goldmann tonometer; Device: Pneumatonometer; Device: Tonopen XL; Device: ICare rebound tonometer | |
| Ocular hypotensive eye drops | Subjects with OAG treated with ocular hypotensive eye drops and no ocular surgical hypotensive treatments.
IOP measurement in different positions. Receives: Device: Goldmann tonometer; Device: Pneumatonometer; Device: Tonopen XL; Device: ICare rebound tonometer | |
| Ocular Hypertension | Subjects with no evidence of glaucomatous damage, but with IOP measurements above 21 mmHg..
IOP measurement in different positions. Receives: Device: Goldmann tonometer; Device: Pneumatonometer; Device: Tonopen XL; Device: ICare rebound tonometer | |
| Control | Subjects with healthy eyes, apart for refraction errors, post cataract surgery, strabismus or amblyopia.
IOP measurement in different positions. Receives: Device: Goldmann tonometer; Device: Pneumatonometer; Device: Tonopen XL; Device: ICare rebound tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of Intra Ocular Pressure Fluctuation with Postural Change in Eyes with Open-angle Glaucoma and Ocular Hypertension, compared to healthy subjects
Interventions are similar for all study groups: The subject will be instructed to stay in a sitting position for 5 minutes. A topical anesthetic eye drop (oxybuprocaine hydrochloride 0.4%) will then be installed in the study eye (necessary procedure made in all IOP examinations as a regular procedure) and the IOP will be measured, in the following order by 4 tonometers: Goldmann tonometer, Pneumatonometer, Tonopen XL, ICare rebound tonometer. The subject will then lie supine for 5 minutes, afterwards will turn to the lateral decubitus position and IOP will be measured again using the same tonometers in the same manner.
The difference between IOP in the sitting and lying body positions will be assessed and compared to the control group.
Measured: Change from baseline 5 minutes following position change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Open Angle 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avner Belkin, Meir Medical Center
- Investigators
- Avner Belkin, M.D, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868502
- Sponsor's protocol ID
- MMC-0026-16
- Status last verified
- Aug 2016
- First submitted
- 27 Jul 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schulzer M, Mikelberg FS, Drance SM. Some observations on the relation between intraocular pressure reduction and the progression of glaucomatous visual loss. Br J Ophthalmol. 1987 Jul;71(7):486-8. doi: 10.1136/bjo.71.7.486.
PubMed 3651360Flammer J, Robert Y, Gloor B. Influence of pindolol and timolol treatment on the visual fields of glaucoma patients. J Ocul Pharmacol. 1986 Fall;2(4):305-11. doi: 10.1089/jop.1986.2.305.
PubMed 3503114Kidd MN, O'Connor M. Progression of field loss after trabeculectomy: a five-year follow-up. Br J Ophthalmol. 1985 Nov;69(11):827-31. doi: 10.1136/bjo.69.11.827.
PubMed 4063249Barkana Y, Anis S, Liebmann J, Tello C, Ritch R. Clinical utility of intraocular pressure monitoring outside of normal office hours in patients with glaucoma. Arch Ophthalmol. 2006 Jun;124(6):793-7. doi: 10.1001/archopht.124.6.793.
PubMed 16769832Barkana Y, Gutfreund S. Measurement of the difference in intraocular pressure between the sitting and lying body positions in healthy subjects: direct comparison of the Icare Pro with the Goldmann applanation tonometer, Pneumatonometer and Tonopen XL. Clin Exp Ophthalmol. 2014 Sep-Oct;42(7):608-14. doi: 10.1111/ceo.12272. Epub 2014 Jan 13.
PubMed 24299102Weber AK, Price J. Pressure differential of intraocular pressure measured between supine and sitting position. Ann Ophthalmol. 1981 Mar;13(3):323-6.
PubMed 7258940Buchanan RA, Williams TD. Intraocular pressure, ocular pulse pressure, and body position. Am J Optom Physiol Opt. 1985 Jan;62(1):59-62. doi: 10.1097/00006324-198501000-00008.
PubMed 3976837Yamabayashi S, Aguilar RN, Hosoda M, Tsukahara S. Postural change of intraocular and blood pressures in ocular hypertension and low tension glaucoma. Br J Ophthalmol. 1991 Nov;75(11):652-5. doi: 10.1136/bjo.75.11.652.
PubMed 1751457Liu JH, Kripke DF, Weinreb RN. Comparison of the nocturnal effects of once-daily timolol and latanoprost on intraocular pressure. Am J Ophthalmol. 2004 Sep;138(3):389-95. doi: 10.1016/j.ajo.2004.04.022.
PubMed 15364220Liu JH, Medeiros FA, Slight JR, Weinreb RN. Diurnal and nocturnal effects of brimonidine monotherapy on intraocular pressure. Ophthalmology. 2010 Nov;117(11):2075-9. doi: 10.1016/j.ophtha.2010.03.026. Epub 2010 Jul 21.
PubMed 20663566Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.
PubMed 22918671Mansouri K, Medeiros FA, Weinreb RN. Effect of glaucoma medications on 24-hour intraocular pressure-related patterns using a contact lens sensor. Clin Exp Ophthalmol. 2015 Dec;43(9):787-95. doi: 10.1111/ceo.12567. Epub 2015 Aug 16.
PubMed 26152693Hirooka K, Takenaka H, Baba T, Takagishi M, Mizote M, Shiraga F. Effect of trabeculectomy on intraocular pressure fluctuation with postural change in eyes with open-angle glaucoma. J Glaucoma. 2009 Dec;18(9):689-91. doi: 10.1097/IJG.0b013e31819c49f4.
PubMed 20010249Hirooka K, Tenkumo K, Nitta E, Sato S. Correlation between Intraocular Pressure Fluctuation with Postural Change and Postoperative Intraocular Pressure in Relation to the Time Course after Trabeculectomy. J Ophthalmol. 2014;2014:801967. doi: 10.1155/2014/801967. Epub 2014 Jul 17.
PubMed 25136454
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trabeculectomy, Glaucoma Drainage Device, Cyclophotocoagulation, and Ocular Hypotensive Eye-drops on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT02868502
- Acronym / sponsor ID
- MMC-0026-16
- Conditions
- Open Angle Glaucoma
- Keywords
- Glaucoma, Open Angle Glaucoma, Intra Ocular Pressure, Ocular Hypotensive Drops, Trabeculectomy, Cyclophotocoagulation, Glaucoma Drainage Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 16 Aug 2016 (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 investigate the effect of trabeculectomy, glaucoma drainage devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP elevation with postural change from the sitting to supine positions in eyes with open-angle glaucoma.
Patients will be assigned to the different study groups according to their past ocular history. Interventions are similar to all study group and no medical therapy alteration will be made.
Detailed description
Visual impairment and blindness due to chronic progressive optic neuropathy developing from glaucoma are major health problems worldwide.
Glaucoma is a progressive, potentially blinding disease, in which the only modifiable risk factor in intraocular pressure. In a significant proportion of patients, the disease progresses despite apparent IOP control(1-3).
One factor which may explain some of this discrepancy is a fluctuation of the IOP during the day, which may be missed in a single visit to the ophthalmologist(4). Although this fluctuation depends to some degree on daily biologic rhythms and the specific type of glaucoma, a constant significant factor responsible for this effect is the IOP-dependent changes of body posture, from sitting or standing to lying down(5). Older studies have shown IOP postural changes in the range of 4-6 mmHg(6-8). Seeing how a typical patient may spend as much as a third of his life in the supine position, knowledge of IOP in this position, and its control, are of great importance in decreasing the chance for irreversible optic nerve damage.
Several studies of Liu JH(9-11) have investigated the effect of hypotensive drops on nocturnal IOP. While prostaglandin analogues (PGA) and carbonic anhydrase inhibitors (CAI) seemed to have a significant nocturnal IOP lowering effect, the effect seen with beta blockers and alpha agonists was minimal. Mansouri et al.(12) recently showed that PGA seem to flatten the IOP-related increase when moving from the sitting to the supine position at nocturnal period, without effecting other circadian IOP-related patterns.
Hirooka Kazuyuki investigated the effect of trabeculectomy on the IOP fluctuations caused by postural changes(13-14). He showed that successful trabeculectomy, which didn't require needling, have significantly decreased the posture-induced IOP changes to less than 3 mmHg.
To the best of our knowledge there is no data regarding the effect of glaucoma drainage devices and cyclophotocoagulation on supine IOP.
The purpose of this study is to investigate the effect of different IOP lowering methods, including trabeculectomy, glaucoma drainage devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP with postural change from the sitting to supine positions in eyes with open-angle glaucoma.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy | – | Device: Goldmann tonometer, Device: Pneumatonometer, Device: Tonopen XL, Device: ICare rebound tonometerSubjects with OAG s/p Trabeculectomy. IOP measurement in different positions. |
| Ahmed Glaucoma Valve implantation | – | Device: Goldmann tonometer, Device: Pneumatonometer, Device: Tonopen XL, Device: ICare rebound tonometerSubjects with OAG s/p Ahmed valve implantation. IOP measurement in different positions. |
| Cyclophotocoagulation | – | Device: Goldmann tonometer, Device: Pneumatonometer, Device: Tonopen XL, Device: ICare rebound tonometerSubjects with OAG s/p Cyclophotocoagulation. IOP measurement in different positions. |
| Ocular hypotensive eye drops | – | Device: Goldmann tonometer, Device: Pneumatonometer, Device: Tonopen XL, Device: ICare rebound tonometerSubjects with OAG treated with ocular hypotensive eye drops and no ocular surgical hypotensive treatments. IOP measurement in different positions. |
| Ocular Hypertension | – | Device: Goldmann tonometer, Device: Pneumatonometer, Device: Tonopen XL, Device: ICare rebound tonometerSubjects with no evidence of glaucomatous damage, but with IOP measurements above 21 mmHg.. IOP measurement in different positions. |
| Control | – | Device: Goldmann tonometer, Device: Pneumatonometer, Device: Tonopen XL, Device: ICare rebound tonometerSubjects with healthy eyes, apart for refraction errors, post cataract surgery, strabismus or amblyopia. IOP measurement in different positions. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with open angle glaucoma with past ocular history of surgical treatment (trabeculectomy, implantation of an Ahmed glaucoma drainage device or cyclophotocoagulation) or are using ocular hypotensive eye drops and subjects with ocular hypertension.
Key inclusion criteria (3 listed)
- OAG patients
- Ocular Hypertension (OHT) patients
- Healthy subjects, without any ocular pathology (except for refraction errors, past cataract surgery, strabismus or amblyopia).
Key exclusion criteria (5 listed)
- Other intraocular surgeries within the past 3 months
- Illness effecting episcleral venous pressure, such as superior vena cava syndrome, thyroid eye disease, orbital masses
- Patients who are unable to maintain supine position for 15 minutes
- Corneal abnormalities: epithelial pathologies, corneal infection, corneal erosions, corneal scars, keratoconus, S/P corneal transplantation (lamellar/full thickness)
- Hypersensitivity to oxybuprocaine hydrochloride
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 |
|---|---|---|
| Goldmann tonometerIOP measurement in the sitting position and lateral decubitus | Device | Ahmed Glaucoma Valve implantation, Control, Cyclophotocoagulation, Ocular Hypertension, Ocular hypotensive eye drops, Trabeculectomy |
| PneumatonometerIOP measurement in the sitting position and lateral decubitus | Device | Ahmed Glaucoma Valve implantation, Control, Cyclophotocoagulation, Ocular Hypertension, Ocular hypotensive eye drops, Trabeculectomy |
| Tonopen XLIOP measurement in the sitting position and lateral decubitus | Device | Ahmed Glaucoma Valve implantation, Control, Cyclophotocoagulation, Ocular Hypertension, Ocular hypotensive eye drops, Trabeculectomy |
| ICare rebound tonometerIOP measurement in the sitting position and lateral decubitus | Device | Ahmed Glaucoma Valve implantation, Control, Cyclophotocoagulation, Ocular Hypertension, Ocular hypotensive eye drops, Trabeculectomy |
Primary outcome
Measurements of Intra Ocular Pressure Fluctuation with Postural Change in Eyes with Open-angle Glaucoma and Ocular Hypertension, compared to healthy subjects
Time frame: Change from baseline 5 minutes following position change
Interventions are similar for all study groups: The subject will be instructed to stay in a sitting position for 5 minutes. A topical anesthetic eye drop (oxybuprocaine hydrochloride 0.4%) will then be installed in the study eye (necessary procedure made in all IOP examinations as a regular procedure) and the IOP will be measured, in the following order by 4 tonometers: Goldmann tonometer, Pneumatonometer, Tonopen XL, ICare rebound tonometer. The subject will then lie supine for 5 minutes, afterwards will turn to the lateral decubitus position and IOP will be measured again using the same tonometers in the same manner. The difference between IOP in the sitting and lying body positions will be assessed and compared to the control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Background: PubMed 3651360Schulzer M, Mikelberg FS, Drance SM. Some observations on the relation between intraocular pressure reduction and the progression of glaucomatous visual loss. Br J Ophthalmol. 1987 Jul;71(7):486-8. doi: 10.1136/bjo.71.7.486.
- Background: PubMed 3503114Flammer J, Robert Y, Gloor B. Influence of pindolol and timolol treatment on the visual fields of glaucoma patients. J Ocul Pharmacol. 1986 Fall;2(4):305-11. doi: 10.1089/jop.1986.2.305.
- Background: PubMed 4063249Kidd MN, O'Connor M. Progression of field loss after trabeculectomy: a five-year follow-up. Br J Ophthalmol. 1985 Nov;69(11):827-31. doi: 10.1136/bjo.69.11.827.
- Background: PubMed 16769832Barkana Y, Anis S, Liebmann J, Tello C, Ritch R. Clinical utility of intraocular pressure monitoring outside of normal office hours in patients with glaucoma. Arch Ophthalmol. 2006 Jun;124(6):793-7. doi: 10.1001/archopht.124.6.793.
- Background: PubMed 24299102Barkana Y, Gutfreund S. Measurement of the difference in intraocular pressure between the sitting and lying body positions in healthy subjects: direct comparison of the Icare Pro with the Goldmann applanation tonometer, Pneumatonometer and Tonopen XL. Clin Exp Ophthalmol. 2014 Sep-Oct;42(7):608-14. doi: 10.1111/ceo.12272. Epub 2014 Jan 13.
- Background: PubMed 7258940Weber AK, Price J. Pressure differential of intraocular pressure measured between supine and sitting position. Ann Ophthalmol. 1981 Mar;13(3):323-6.
- Background: PubMed 3976837Buchanan RA, Williams TD. Intraocular pressure, ocular pulse pressure, and body position. Am J Optom Physiol Opt. 1985 Jan;62(1):59-62. doi: 10.1097/00006324-198501000-00008.
- Background: PubMed 1751457Yamabayashi S, Aguilar RN, Hosoda M, Tsukahara S. Postural change of intraocular and blood pressures in ocular hypertension and low tension glaucoma. Br J Ophthalmol. 1991 Nov;75(11):652-5. doi: 10.1136/bjo.75.11.652.
- Background: PubMed 15364220Liu JH, Kripke DF, Weinreb RN. Comparison of the nocturnal effects of once-daily timolol and latanoprost on intraocular pressure. Am J Ophthalmol. 2004 Sep;138(3):389-95. doi: 10.1016/j.ajo.2004.04.022.
- Background: PubMed 20663566Liu JH, Medeiros FA, Slight JR, Weinreb RN. Diurnal and nocturnal effects of brimonidine monotherapy on intraocular pressure. Ophthalmology. 2010 Nov;117(11):2075-9. doi: 10.1016/j.ophtha.2010.03.026. Epub 2010 Jul 21.
- Background: PubMed 22918671Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.
- Background: PubMed 26152693Mansouri K, Medeiros FA, Weinreb RN. Effect of glaucoma medications on 24-hour intraocular pressure-related patterns using a contact lens sensor. Clin Exp Ophthalmol. 2015 Dec;43(9):787-95. doi: 10.1111/ceo.12567. Epub 2015 Aug 16.
- 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.
Avner Belkin, M.D principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by Meir Medical Center.
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 3 inclusion and 5 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 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Ortal Fogel Tempelhof, M.D (+972528518303, talifog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of Intra Ocular Pressure Fluctuation with Postural Change in Eyes with Open-angle Glaucoma and Ocular Hypertension, compared to healthy subjects (time frame: Change from baseline 5 minutes following position change). 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 NCT02868502, which also lists 14 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 2016.