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Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma

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ClinicalTrials.gov Identifier: NCT02868502
Recruitment Status : Unknown
Verified August 2016 by Avner Belkin, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Avner Belkin, Meir Medical Center

Brief 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.

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.


Condition or disease Intervention/treatment
Open Angle Glaucoma Device: Goldmann tonometer Device: Pneumatonometer Device: Tonopen XL Device: ICare rebound tonometer

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 Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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
Study Start Date : September 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017


Group/Cohort Intervention/treatment
Trabeculectomy
Subjects with OAG s/p Trabeculectomy. IOP measurement in different positions.
Device: Goldmann tonometer
IOP measurement in the sitting position and lateral decubitus

Device: Pneumatonometer
IOP measurement in the sitting position and lateral decubitus

Device: Tonopen XL
IOP measurement in the sitting position and lateral decubitus

Device: ICare rebound tonometer
IOP measurement in the sitting position and lateral decubitus

Ahmed Glaucoma Valve implantation
Subjects with OAG s/p Ahmed valve implantation. IOP measurement in different positions.
Device: Goldmann tonometer
IOP measurement in the sitting position and lateral decubitus

Device: Pneumatonometer
IOP measurement in the sitting position and lateral decubitus

Device: Tonopen XL
IOP measurement in the sitting position and lateral decubitus

Device: ICare rebound tonometer
IOP measurement in the sitting position and lateral decubitus

Cyclophotocoagulation
Subjects with OAG s/p Cyclophotocoagulation. IOP measurement in different positions.
Device: Goldmann tonometer
IOP measurement in the sitting position and lateral decubitus

Device: Pneumatonometer
IOP measurement in the sitting position and lateral decubitus

Device: Tonopen XL
IOP measurement in the sitting position and lateral decubitus

Device: ICare rebound tonometer
IOP measurement in the sitting position and lateral decubitus

Ocular hypotensive eye drops

Subjects with OAG treated with ocular hypotensive eye drops and no ocular surgical hypotensive treatments.

IOP measurement in different positions.

Device: Goldmann tonometer
IOP measurement in the sitting position and lateral decubitus

Device: Pneumatonometer
IOP measurement in the sitting position and lateral decubitus

Device: Tonopen XL
IOP measurement in the sitting position and lateral decubitus

Device: ICare rebound tonometer
IOP measurement in the sitting position and lateral decubitus

Ocular Hypertension

Subjects with no evidence of glaucomatous damage, but with IOP measurements above 21 mmHg..

IOP measurement in different positions.

Device: Goldmann tonometer
IOP measurement in the sitting position and lateral decubitus

Device: Pneumatonometer
IOP measurement in the sitting position and lateral decubitus

Device: Tonopen XL
IOP measurement in the sitting position and lateral decubitus

Device: ICare rebound tonometer
IOP measurement in the sitting position and lateral decubitus

Control

Subjects with healthy eyes, apart for refraction errors, post cataract surgery, strabismus or amblyopia.

IOP measurement in different positions.

Device: Goldmann tonometer
IOP measurement in the sitting position and lateral decubitus

Device: Pneumatonometer
IOP measurement in the sitting position and lateral decubitus

Device: Tonopen XL
IOP measurement in the sitting position and lateral decubitus

Device: ICare rebound tonometer
IOP measurement in the sitting position and lateral decubitus




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • OAG patients
  • Ocular Hypertension (OHT) patients
  • Healthy subjects, without any ocular pathology (except for refraction errors, past cataract surgery, strabismus or amblyopia).

Exclusion Criteria:

  • 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

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): NCT02868502


Contacts
Contact: Ortal Fogel Tempelhof, M.D +972528518303 talifog@gmail.com

Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Avner Belkin, M.D Meir Medical Center

Publications:

Responsible Party: Avner Belkin, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02868502     History of Changes
Other Study ID Numbers: MMC-0026-16
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Avner Belkin, Meir Medical Center:
Glaucoma
Open Angle Glaucoma
Intra Ocular Pressure
Ocular Hypotensive Drops
Trabeculectomy
Cyclophotocoagulation
Glaucoma Drainage Device

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Antihypertensive Agents
Pharmaceutical Solutions