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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Lens Fragmentation by means of a femtosecondlaser
Manual Phacoemulsification
Sponsored by
Technolas Perfect Vision GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Lens Fragmentation, Cataract, Phacoemulsification, Femtosecond Laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Maxivision Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Femtec Groupe A

Manual Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Less or equal severe adverse events in Group A compared to group B. p<0.05 will be considered statistically significant.
Easy of phacoemulsification as subjectively perceived by the surgeon during surgery

Full Information

First Posted
June 8, 2011
Last Updated
May 19, 2015
Sponsor
Technolas Perfect Vision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01373853
Brief Title
A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery
Acronym
1103
Official Title
A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technolas Perfect Vision GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Lens Fragmentation, Cataract, Phacoemulsification, Femtosecond Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femtec Groupe A
Arm Type
Experimental
Arm Description
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery
Arm Title
Manual Group B
Arm Type
Active Comparator
Arm Description
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Intervention Type
Procedure
Intervention Name(s)
Lens Fragmentation by means of a femtosecondlaser
Intervention Description
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
Intervention Type
Procedure
Intervention Name(s)
Manual Phacoemulsification
Intervention Description
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Easy of phacoemulsification as subjectively perceived by the surgeon during surgery
Time Frame
time fo surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Maxivision Eye Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India

12. IPD Sharing Statement

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

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