Clinical Trials Logo

Clinical 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.

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02868502
Study type Observational
Source Meir Medical Center
Contact Ortal Fogel Tempelhof, M.D
Phone +972528518303
Email talifog@gmail.com
Status Not yet recruiting
Phase N/A
Start date September 2016
Completion date August 2017

See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Terminated NCT03611530 - CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma N/A
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Completed NCT02272569 - STARflo European Safety and Efficacy Study N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT00941525 - Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure Phase 4
Completed NCT00539526 - Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues Phase 4
Completed NCT00121147 - Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan N/A
Active, not recruiting NCT05035394 - Swedish Microinvasive Glaucoma Surgery Study (SMIGS) N/A
Completed NCT03450629 - Evaluation of Safety and Efficacy of PDP-716 Phase 3
Active, not recruiting NCT06061718 - Travoprost Intraocular Implant in Conjunction With Cataract Surgery Phase 3
Recruiting NCT05241938 - PSLT Compared to Prostaglandin Analogue Eye Drops N/A
Completed NCT01342406 - Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
Completed NCT02250612 - SYL040012, Treatment for Open Angle Glaucoma Phase 2
Completed NCT01937312 - Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue Phase 4
Terminated NCT01983579 - TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection Phase 4
Completed NCT01937299 - Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z® Phase 4
Completed NCT01229982 - A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma Phase 2
Recruiting NCT00440336 - Comparison of Efficacy of Two Groups of Glaucoma Drops (Xalatan vs.Cosopt) in Reducing Eye Pressure Following Laser (SLT)Treatment in the Management of Glaucoma. N/A