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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Cataract; Glaucoma

Treatments: Procedure: Femtolaser surgery; Procedure: Phacoemulsification

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02835482

AGC_2014-19

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Patient with glaucoma

Experimental group

Description:

Patient eligible for bilateral cataract surgery, with glaucoma. Each patient is his own control. The patient is treated with femtolaser surgery for one eye and with phacoemulsification for the other eye.

Treatment:

Procedure: Phacoemulsification

Procedure: Femtolaser surgery

Patient without glaucoma

Other group

Description:

Patient eligible for bilateral cataract surgery, without glaucoma. Each patient is his own control. The patient is treated with femtolaser surgery for one eye and with the phacoemulsification for the other eye.

Treatment:

Procedure: Phacoemulsification

Procedure: Femtolaser surgery