NCT01769313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

January 14, 2013

Last Update Submit

October 30, 2014

Conditions

Cataract

Keywords

CataractLaser-assistedFemtosecond

Outcome Measures

Primary Outcomes (1)

  • 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

    6 Month postoeprative

Secondary Outcomes (3)

  • ΔELP is different between Group A and Group B

    6 months postoperative

  • ΔFlare is different between Group A and Group B

    6 months postoperative

  • SEQ Prediction Error is different between Group A and Group B

    6 months postoperatvie

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: Laser-assisted cataract surgery

Group B

ACTIVE COMPARATOR

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

Device: Manually performed cataract surgery

Interventions

Laser-assisted cataract surgeryDEVICE

The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery

Group A
Manually performed cataract surgeryDEVICE

The anterior capsulotomy and lens fragmentation will be performed manually.

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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.
  • 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
  • Patients who are pregnant or nursing
  • Patients who do not give informed consent
  • Patients with concentration disorders, epilepsy and other complicating diseases
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäts-Augenklinik Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Gerd U Auffarth, Prof. Dr.

    Universitäts-Augenklinik Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

DE(1)