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

NCT02835482 | Terminated

• 1 other identifier: AGC_2014-19
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient with glaucoma

EXPERIMENTAL

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.

Procedure: Femtolaser surgery; Procedure: Phacoemulsification

Patient without glaucoma

OTHER

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.

Procedure: Femtolaser surgery; Procedure: Phacoemulsification

Interventions

Femtolaser surgery PROCEDURE

Patient with glaucoma; Patient without glaucoma

Phacoemulsification PROCEDURE

Patient with glaucoma; Patient without glaucoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Glaucoma; Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 18, 2016
• Study Start: April 14, 2016
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

FR (1)