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

Primary Purpose

Glaucoma, Cataract

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Femtolaser surgery
Phacoemulsification
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondation ophtalmique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patient with glaucoma

Patient without glaucoma

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2016
Last Updated
December 20, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02835482
Brief Title
Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery
Acronym
FEMTOHTO
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulties encountered with patients inclusion and femtolaser availability
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Cataract

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with glaucoma
Arm Type
Experimental
Arm 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.
Arm Title
Patient without glaucoma
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Femtolaser surgery
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Primary Outcome Measure Information:
Title
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.
Time Frame
within the first 3 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondation ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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