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

Cataract Clinical Trial

— FEMTOHTO  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02835482
• Other study ID #: AGC_2014-19
• Status: Terminated
• Phase: N/A
• First received: July 11, 2016
• Last updated: December 20, 2017
• Start date: April 14, 2016
• Est. completion date: November 16, 2017

Study information

• Verified date: December 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Procedure:
• Femtolaser surgery

• Phacoemulsification

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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