A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery (1103)

May 19, 2015 updated by: Technolas Perfect Vision GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Maxivision Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • On a keratometric map of the cornea, the minimal and maximal K-values of the central 3mm zone must not differ by more than 5 dioptres. (exclusion criterium for Group A only)
  • The maximum K- value may not exceed 60 D, the minimal value may not be smaller than 37 D. (exclusion criterium for Group A only)
  • Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light. (exclusion criterium for Group A only)
  • 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
  • Abnormal examination results from Orbscan (exclusion criterium for Group A only)
  • Patients with an autoimmune disease, collagenosis or clinically significant atopy.
  • Patients who are pregnant or nursing.
  • Patients who do not give informed consent.
  • ACD < 2.4 mm or ACD > 4.5 mm as measured by ultrasonic examination (exclusion criterium for Group A only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femtec Groupe A
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
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
Active Comparator: Manual Group B
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Procedure: Manual Phacoemulsification
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: at time of surgery
at time of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 1-Day Follow-UP
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.
Time Frame: 1-Day Follow-UP
1-Day Follow-UP
Easy of phacoemulsification as subjectively perceived by the surgeon during surgery
Time Frame: time fo surgery
time fo surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technolas Perfect Vision GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimate)

June 15, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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