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

Not Applicable

Terminated

• Conditions: Cataract; Glaucoma
• Interventions: Procedure: Femtolaser surgery; Procedure: Phacoemulsification

• Registration Number: NCT02835482
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Primary Completion: 2017-11-16
• Study Completion: 2017-11-16
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient without glaucoma	Femtolaser surgery	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.
Patient with glaucoma	Phacoemulsification	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.
Patient without glaucoma	Phacoemulsification	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.
Patient with glaucoma	Femtolaser surgery	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fondation ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France