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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02835482

Acronym

FEMTOHTO

Enrollment

Registered

2016-07-18

Start date

2016-04-14

Completion date

2017-11-16

Last updated

2017-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma

Brief summary

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.

Interventions

PROCEDUREFemtolaser surgery

PROCEDUREPhacoemulsification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* scheduled bilateral cataract surgery * bilateral known glaucoma confirmed at the preoperative consultation (glaucoma group) or absence of glaucoma in both eyes at confirmed the preoperative consultation (control group).

Exclusion criteria

* ophthalmologic pathology known other than glaucoma * diabetes * untreated hypertension * multiple sclerosis * Graves' disease * sarcoidosis * patient taking toxic drug for the optic nerve and the retina * neurodegenerative disease * all general diseases that can affect the ocular structures * eye surgery history * patient's opposition to participation in the study, according to the law on research into routine care * absence of affiliation to social security or to universal medical coverage * legally protected patient * pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
In patient with glaucoma, measure of the thickness of the ganglion cell complex in the operated eye with femtosecond laser versus the operated eye with phacoemulsification.	within the first 3 months after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026