Last reviewed · How we verify

NCT02835482: FEMTOHTO

Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery

Terminated NA Last updated 21 December 2017
What this trial tests

NA trial testing Femtolaser surgery in Glaucoma in 15 participants. Terminated before completion.

Timeline
14 April 2016
Primary endpoint
16 November 2017
16 November 2017

Quick facts

Lead sponsorFondation Ophtalmologique Adolphe de Rothschild
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment15
Start date14 April 2016
Primary completion16 November 2017
Estimated completion16 November 2017
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild — full company profile →

Who can join

Eligibility, any sex, with Glaucoma or Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase). If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve. No data has been published to date on potential adverse effects of femtolaser cataract surgery performed in patients with glaucomatous optic neuropathy. Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss of this layer. The investigators propose to evaluate the effects of elevated intraocular pressure in glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Glaucoma

Currently open trials in the same condition.

Other Fondation Ophtalmologique Adolphe de Rothschild trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02835482.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing