MedDataX Logo

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

NCT ID: NCT02835482

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-14

Study Completion Date

2017-11-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with glaucoma

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.

Group Type EXPERIMENTAL

Femtolaser surgery

Intervention Type PROCEDURE

Phacoemulsification

Intervention Type PROCEDURE

Patient without glaucoma

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.

Group Type OTHER

Femtolaser surgery

Intervention Type PROCEDURE

Phacoemulsification

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Femtolaser surgery

Intervention Type PROCEDURE

Phacoemulsification

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fondation ophtalmique Adolphe de Rothschild

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AGC_2014-19

Identifier Type: -

Identifier Source: org_study_id