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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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Clalit Health Services

Status

Unknown

Conditions

Open Angle Glaucoma

Treatments

Device: ICare rebound tonometer
Device: Goldmann tonometer
Device: Pneumatonometer
Device: Tonopen XL

Study type

Observational

Funder types

Other

Identifiers

NCT02868502
MMC-0026-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

150 participants in 6 patient groups

Trabeculectomy
Description:
Subjects with OAG s/p Trabeculectomy. IOP measurement in different positions.
Treatment:
Device: Pneumatonometer
Device: ICare rebound tonometer
Device: Goldmann tonometer
Device: Tonopen XL
Ahmed Glaucoma Valve implantation
Description:
Subjects with OAG s/p Ahmed valve implantation. IOP measurement in different positions.
Treatment:
Device: Pneumatonometer
Device: ICare rebound tonometer
Device: Goldmann tonometer
Device: Tonopen XL
Cyclophotocoagulation
Description:
Subjects with OAG s/p Cyclophotocoagulation. IOP measurement in different positions.
Treatment:
Device: Pneumatonometer
Device: ICare rebound tonometer
Device: Goldmann tonometer
Device: Tonopen XL
Ocular hypotensive eye drops
Description:
Subjects with OAG treated with ocular hypotensive eye drops and no ocular surgical hypotensive treatments. IOP measurement in different positions.
Treatment:
Device: Pneumatonometer
Device: ICare rebound tonometer
Device: Goldmann tonometer
Device: Tonopen XL
Ocular Hypertension
Description:
Subjects with no evidence of glaucomatous damage, but with IOP measurements above 21 mmHg.. IOP measurement in different positions.
Treatment:
Device: Pneumatonometer
Device: ICare rebound tonometer
Device: Goldmann tonometer
Device: Tonopen XL
Control
Description:
Subjects with healthy eyes, apart for refraction errors, post cataract surgery, strabismus or amblyopia. IOP measurement in different positions.
Treatment:
Device: Pneumatonometer
Device: ICare rebound tonometer
Device: Goldmann tonometer
Device: Tonopen XL

Trial contacts and locations

0

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Central trial contact

Ortal Fogel Tempelhof, M.D

Data sourced from clinicaltrials.gov

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