A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery

NCT01373853 | Completed Phase 3 DMC

• 1 other identifier: 1103
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size. The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation the required ultrasound energy used for phacoemulsification can be reduced in a safe and effective way.

Conditions

Cataract

Keywords

Lens Fragmentation; Cataract; Phacoemulsification; Femtosecond Laser

Outcome Measures

Primary Outcomes (1)

• Observation of the applied Effective Phaco Time (EPT) for Pahcoemulsifikation during surgery. The observed Effective Phaco Time in Group A should be significantly lower than in group B. Statistically significant difference at p<0.05.

  at time of surgery

Secondary Outcomes (3)

• Less or equal adverse events in Group A compared to group B (e.g. retinal detachment, IOL malposition). p<0.05 will be considered statistically significant.

  1-Day Follow-UP

• Less or equal severe adverse events in Group A compared to group B. p<0.05 will be considered statistically significant.

  1-Day Follow-UP

• Easy of phacoemulsification as subjectively perceived by the surgeon during surgery

  time fo surgery

Study Arms (2)

Femtec Groupe A

EXPERIMENTAL

In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery

Procedure: Lens Fragmentation by means of a femtosecondlaser

Manual Group B

ACTIVE COMPARATOR

Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually

Procedure: Manual Phacoemulsification

Interventions

Lens Fragmentation by means of a femtosecondlaser PROCEDURE

In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.

Femtec Groupe A

Manual Phacoemulsification PROCEDURE

Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually

Manual Group B

Eligibility Criteria

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

You may qualify if:

• Clear corneal media
• Patients must be at least 18 years of age.

You may not qualify if:

• Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.
• Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
• Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
• Known sensitivity to planned concomitant medications.
• Patients with disorders of the ocular muscle, such as nystagmus or strabismus
• Keratoconus
• Patients with woundhealing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
• Abnormal examination results from slit lamp, Fundus, IOL Master
• Patients with an autoimmune disease, collagenosis or clinically significant atopy.
• Patients who are pregnant or nursing.
• Patients who do not give informed consent.

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (1)

Maxivision Eye Hospital

Hyderabad, Andhra Pradesh, 500082, India

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 15, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

IN (1)