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A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Laser-assisted cataract surgery
Manually performed 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 focused on measuring Cataract, Laser-assisted, Femtosecond

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
  • Patients must have read, understood and signed the Patient Information
  • Patients are willing and able to return for follow-up examinations
  • Topographic Astigmatism ≤ 1.5 dpt
  • Patient will get a monofocal IOL (Envista) implanted

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 5D (exclusion criterium for Group A only)
  • The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D (exclusion criterium for Group A only)
  • Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light (exclusion criteria 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.
  • Manifest Glaucoma
  • Patients presenting a clear lens (clear lens exchange)
  • 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
  • Patients with keratoconus or keratectasia
  • Patients with connective tissue weakness
  • Patients who are blind on one eye
  • Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
  • Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable
  • Abnormal examination results from Orbscan (exclusion criteria for Group A only; , age related changes are acceptable
  • Patients who are pregnant or nursing
  • Patients who do not give informed consent
  • Patients with concentration disorders, epilepsy and other complicating diseases
  • Patients regularly taking medicines that could influence the result of the treatment
  • Patients who are participating in another ophthalmological clinical study
  • Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured as from the corneal endothelium.

Sites / Locations

  • Universitäts-Augenklinik Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually.

Outcomes

Primary Outcome Measures

ΔROverlap is different between Group A and Group B
• The decentration, ΔROverlap, between implanted IOL and capsulotomy aperture is different in Group A as compared to Group B. p<0.05 will be considered statistically significant. The study end point will be determined for all follow-up examination periods; the purpose criterion should be achieved by the 6 month examination at the latest. Goal:To evaluate a significant difference (p<0.05) of ΔROverlap between Group A and Group B

Secondary Outcome Measures

ΔELP is different between Group A and Group B
• The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p<0.05 will be considered statistically significant. The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest. Goal: To evaluate a significant difference (p<0.05) of Δ Flare between Group A and Group B
ΔFlare is different between Group A and Group B
• The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p<0.05 will be considered statistically significant. The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest. Goal: To evaluate a significant difference (p<0.05) of Δ Flare between Group A and Group B
SEQ Prediction Error is different between Group A and Group B
• The difference, SEQ Prediction Error, between target refraction SEQ and actual SEQ is different in Group A as compared to Group B. p<0.05 will be considered statistically significant. The study end point will be determined for all follow-up examination periods, the purpose criterion should be achieved by the 6 month examination at the latest. Goal: To evaluate a significant difference (p<0.05) of the SEQ Prediction Error between Group A and Group B

Full Information

First Posted
January 14, 2013
Last Updated
October 30, 2014
Sponsor
Technolas Perfect Vision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01769313
Brief Title
A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery
Official Title
A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 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 (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.
Detailed Description
A detailed pre-operative examination will ensure that every interested and willing patient fulfills the inclusion criteria of this study. For the proposed contralateral eye study between 30 and 35 patients will be enrolled whereas one eye will randomized undergo a manual cataract surgery and the other one a laser assisted cataract surgery. In total between 60 and 70 eyes will be included in the study. Pre-operative examinations are included to confirm to the clinical practice. Examinations on the day of surgery and any occurrence during the procedure are also listed. Post-operative examinations, which should document any occurrence, the outcome of and possible differences between the treatment techniques, are to be carried out after 1 day, 1 week, 1 month, 3 months and 6 months. After 6 month a final report including the study results will be produced. The study is carried out in compliance with MEDDEV 2.7.1 Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies, ICH E6 (R1) Good Clinical Practice (GCP), Declaration of Helsinki as well as the applicable local regulations such as notification requirements and current order of profession of the primary investigators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Laser-assisted, Femtosecond

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually.
Intervention Type
Device
Intervention Name(s)
Laser-assisted cataract surgery
Intervention Description
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Intervention Type
Device
Intervention Name(s)
Manually performed cataract surgery
Intervention Description
The anterior capsulotomy and lens fragmentation will be performed manually.
Primary Outcome Measure Information:
Title
ΔROverlap is different between Group A and Group B
Description
• The decentration, ΔROverlap, between implanted IOL and capsulotomy aperture is different in Group A as compared to Group B. p<0.05 will be considered statistically significant. The study end point will be determined for all follow-up examination periods; the purpose criterion should be achieved by the 6 month examination at the latest. Goal:To evaluate a significant difference (p<0.05) of ΔROverlap between Group A and Group B
Time Frame
6 Month postoeprative
Secondary Outcome Measure Information:
Title
ΔELP is different between Group A and Group B
Description
• The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p<0.05 will be considered statistically significant. The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest. Goal: To evaluate a significant difference (p<0.05) of Δ Flare between Group A and Group B
Time Frame
6 months postoperative
Title
ΔFlare is different between Group A and Group B
Description
• The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p<0.05 will be considered statistically significant. The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest. Goal: To evaluate a significant difference (p<0.05) of Δ Flare between Group A and Group B
Time Frame
6 months postoperative
Title
SEQ Prediction Error is different between Group A and Group B
Description
• The difference, SEQ Prediction Error, between target refraction SEQ and actual SEQ is different in Group A as compared to Group B. p<0.05 will be considered statistically significant. The study end point will be determined for all follow-up examination periods, the purpose criterion should be achieved by the 6 month examination at the latest. Goal: To evaluate a significant difference (p<0.05) of the SEQ Prediction Error between Group A and Group B
Time Frame
6 months postoperatvie

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 Patients must have read, understood and signed the Patient Information Patients are willing and able to return for follow-up examinations Topographic Astigmatism ≤ 1.5 dpt Patient will get a monofocal IOL (Envista) implanted 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 5D (exclusion criterium for Group A only) The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D (exclusion criterium for Group A only) Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light (exclusion criteria 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. Manifest Glaucoma Patients presenting a clear lens (clear lens exchange) 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 Patients with keratoconus or keratectasia Patients with connective tissue weakness Patients who are blind on one eye Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study. Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable Abnormal examination results from Orbscan (exclusion criteria for Group A only; , age related changes are acceptable Patients who are pregnant or nursing Patients who do not give informed consent Patients with concentration disorders, epilepsy and other complicating diseases Patients regularly taking medicines that could influence the result of the treatment Patients who are participating in another ophthalmological clinical study Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured as from the corneal endothelium.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd U Auffarth, Prof. Dr.
Organizational Affiliation
Universitäts-Augenklinik Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts-Augenklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

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A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

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