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Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Femtosecond laser cataract surgery
Manual cataract surgery
Sponsored by
Technolas Perfect Vision GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have read, understood and signed the Patient Information
  • Patients are willing and able to return for follow-up examinations
  • Clear corneal media
  • Cataract grade (nuclear) from I to V according to LOCS III
  • Patients must be at least 40 years of age

Exclusion Criteria:

  • Patients presenting a clear lens (clear lens exchange)
  • Glaucoma and suspected glaucoma
  • Patients with pre-existing proliferative diabetic retinopathy (mild and tight controlled diabetes symptoms, without retinopathy and non-proliferative diabetic retinopathy, can be included.)
  • Retinal disorders
  • Rheumatic diseases
  • Occlusion of retinal vessels
  • Pellucid marginal degeneration
  • Herpes zoster or herpes simplex keratitis
  • Heavy vascularization of the ocular tissue
  • Epilepsy
  • Recurrent corneal erosion
  • Severe basement membrane disease
  • Patients who suffer from severe wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses,endocrine diseases, lupus, rheumatoid arthritis, collagenosis, or clinically significant atopy
  • Patients suffering from AIDS or HIV.
  • Chemosis
  • Significant loss of stability of the conjunctiva
  • Nystagmus
  • On a keratometric map of the cornea, the minimum and maximum K-values of the central 3 mm zone must not differ by more than 5 D.
  • The maximum K-values must not exceed 60 D. The minimum value must not be smaller than 37 D.
  • Patients who are pregnant or nursing.
  • Patients who are blind in the fellow eye.
  • Known sensitivity to planned concomitant medications.
  • Patients with a recurrent or active ocular or uncontrolled eyelid disease.
  • Subjects with a poorly dilating pupil.
  • Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm
  • Presence of blood or other material in the anterior chamber.
  • A history of lens instability (eg. posterior polar cataract, traumatic cataract) or zonular instability

Sites / Locations

  • Gemini Eye Clinic
  • MaxiVision Laser Centre Private Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Femtosecond laser cataract surgery

Manual cataract surgery

Arm Description

"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.

"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation

Outcomes

Primary Outcome Measures

Effective Phacoemulsification Time
The effective phacoemulsification time (EPT) used the "Laser group" (pooled from all grades) during phacoemulsification is lower than or equal to that in the "Manual group" (pooled from all grades); p<0.05 will be considered statistically significant.

Secondary Outcome Measures

Adverse Events
Less or equal adverse events (e.g. retinal detachment, IOL malposition, etc.) in "Laser group" (pooled from all cataract grades) compared with "Manual group" (pooled from all cataract grades); p<0.05 will be considered statistically significant. The secondary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures.

Full Information

First Posted
October 23, 2013
Last Updated
March 13, 2014
Sponsor
Technolas Perfect Vision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01971177
Brief Title
Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure
Official Title
A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study is a randomized, controlled, open, prospective, multi-centre, multi-surgeon post-market-clinical-follow-up study to investigate the impact of cataract grade on the efficacy and safety of femtosecond laser assisted lens fragmentation to support phacoemulsification of the cataractous lens prior to intraocular lens (IOL) implantation.
Detailed Description
The purpose of the multi-centre, multi-surgeon, randomized, controlled, prospective, post-market-clinical-follow-up study clinical study is to investigate the impact of cataract grade on the safety and efficacy of femtosecond laser assisted lens fragmentation for cataract surgery by using VICTUS femtosecond laser platform. In this study patients with different cataract grades [judged by lens opacity classification system (LOCS) III on nuclear opalescence) will be randomly assigned to either a manual group or a laser group, and aspects on efficacy and safety will be investigated. The sponsor and the investigators ensure, that all relevant documents are approved by their institutional review board / institutional ethics committee (IRB/IEC), or if not using their institution's IRB/IEC, approved by the reviewing central IRB/IEC prior to entering any subjects in the study. To avoid any potential bias during the process of patient assignment and in order to observe fair and true clinical significance a block randomization method will be employed and applied during the study. Subjects are regarded as enrolled to the clinical trial population as soon as they have signed and received the patient informed consent form (ICF) and underwent preoperative examinations. The sponsor's clinical group will accompany and monitor this study in respect to patient enrolment, eligibility control, randomization process, postoperative monitoring and data collection in accordance with the applicable regulations and the specifications required by the sponsor. All medical information obtained at each study visit will be recorded in the subject's record (source documentation) in real time as it is collected and then transcribed onto the case report form (CRF) by site personnel.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femtosecond laser cataract surgery
Arm Type
Experimental
Arm Description
"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.
Arm Title
Manual cataract surgery
Arm Type
Active Comparator
Arm Description
"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation
Intervention Type
Device
Intervention Name(s)
Femtosecond laser cataract surgery
Intervention Description
The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens. The correct positioning of the cuts inside the lens can be verified by means of an optical coherence tomograph (OCT) before starting the laser assisted fragmentation process. Various surgical patterns will be used within this study. For each pattern different geometry/laser parameters can be adjusted individually according to each patient's cataract status. All the patients who are enrolled in the laser groups (all cataract grades) will be treated with femtosecond laser assisted capsulotomy before the femtosecond laser assisted lens fragmentation by VICTUS femtosecond laser platform.
Intervention Type
Procedure
Intervention Name(s)
Manual cataract surgery
Intervention Description
"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation
Primary Outcome Measure Information:
Title
Effective Phacoemulsification Time
Description
The effective phacoemulsification time (EPT) used the "Laser group" (pooled from all grades) during phacoemulsification is lower than or equal to that in the "Manual group" (pooled from all grades); p<0.05 will be considered statistically significant.
Time Frame
This criterion should be achieved at the day of treatment.
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Less or equal adverse events (e.g. retinal detachment, IOL malposition, etc.) in "Laser group" (pooled from all cataract grades) compared with "Manual group" (pooled from all cataract grades); p<0.05 will be considered statistically significant. The secondary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures.
Time Frame
This purpose criterion should be achieved intraoperative, at 1 day, 1 week and 1 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have read, understood and signed the Patient Information Patients are willing and able to return for follow-up examinations Clear corneal media Cataract grade (nuclear) from I to V according to LOCS III Patients must be at least 40 years of age Exclusion Criteria: Patients presenting a clear lens (clear lens exchange) Glaucoma and suspected glaucoma Patients with pre-existing proliferative diabetic retinopathy (mild and tight controlled diabetes symptoms, without retinopathy and non-proliferative diabetic retinopathy, can be included.) Retinal disorders Rheumatic diseases Occlusion of retinal vessels Pellucid marginal degeneration Herpes zoster or herpes simplex keratitis Heavy vascularization of the ocular tissue Epilepsy Recurrent corneal erosion Severe basement membrane disease Patients who suffer from severe wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses,endocrine diseases, lupus, rheumatoid arthritis, collagenosis, or clinically significant atopy Patients suffering from AIDS or HIV. Chemosis Significant loss of stability of the conjunctiva Nystagmus On a keratometric map of the cornea, the minimum and maximum K-values of the central 3 mm zone must not differ by more than 5 D. The maximum K-values must not exceed 60 D. The minimum value must not be smaller than 37 D. Patients who are pregnant or nursing. Patients who are blind in the fellow eye. Known sensitivity to planned concomitant medications. Patients with a recurrent or active ocular or uncontrolled eyelid disease. Subjects with a poorly dilating pupil. Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm Presence of blood or other material in the anterior chamber. A history of lens instability (eg. posterior polar cataract, traumatic cataract) or zonular instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Stodulka, Dr. med
Organizational Affiliation
Gemini clinic, Zlin, Czech Republic 76001
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kasu Prasad Reddy, MD
Organizational Affiliation
MaxiVision Laser Centre Private Limited, Hyderabad, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
N Sreelakshmi, MD
Organizational Affiliation
MaxiVision Laser Centre Private Limited, Hyderabad, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Slade, MD
Organizational Affiliation
Slade & Baker Vision Center
Official's Role
Study Chair
Facility Information:
Facility Name
Gemini Eye Clinic
City
Zlin
ZIP/Postal Code
76001
Country
Czech Republic
Facility Name
MaxiVision Laser Centre Private Limited
City
Hyderabad
ZIP/Postal Code
500082
Country
India

12. IPD Sharing Statement

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Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure

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