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

August 14, 2016 updated by: Avner Belkin, Meir Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ortal Fogel Tempelhof, M.D
  • Phone Number: +972528518303
  • Email: talifog@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline 5 minutes following position change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Avner Belkin, M.D, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 14, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 14, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC-0026-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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