NCT01025050

Brief Summary

This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

November 25, 2009

Last Update Submit

June 8, 2011

Conditions

Presbyopia

Keywords

PresbyopiaIntrastromalFemtosecond Laserminimal-invasiveINTRACOREnhance Near Visual Acuity

Outcome Measures

Primary Outcomes (1)

  • The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%.

    6 months follow up

Secondary Outcomes (1)

  • The proportion of treated eyes that lose more than two lines of best corrected visual acuity (BSCVA). This proportion should be no greater than 5 %.

    6 months follow up

Study Arms (3)

Group A

EXPERIMENTAL

In this group the smallest ring diameter will be applied.

Procedure: Intrastromal Correction of Presbyopia

Group B

EXPERIMENTAL

In this group the intermediate ring diameter will be applied.

Procedure: Intrastromal Correction of Presbyopia

Group C

EXPERIMENTAL

In this group the biggest ring diameter will be applied.

Procedure: Intrastromal Correction of Presbyopia

Interventions

Intrastromal Correction of PresbyopiaPROCEDURE

On all patients an intrastromal pattern consisting of concentric rings will be applied.

Group AGroup BGroup C

Eligibility Criteria

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

You may qualify if:

  • Age: at least 18 years old
  • Patients must have read, understood and signed the Patient Information
  • Patients are willing and able to return for follow-up examinations
  • Stable distance refraction
  • Manifested Refraction (see Table 1 for more details) :
  • Cylinder: -0.5 D to 0 D
  • Sphere: 0.25 D to 1.25 D
  • Spherical equivalent: Minimum 0.25 D
  • Best corrected distance visual acuity of the eye to be treated at least 0.8
  • Subjects must have presbyopia as determined by an age-related need for optical aid (≥ +1.5 D) for reading with their best distance correction.

You may not qualify if:

  • Minimum cornea thickness \< 500 µm
  • Ocular dominance (only non-dominant eyes should be included)
  • Uncorrected Near Visual Acuity of 0.5 or better
  • Difference between manifested and cycloplegic refraction of \> 0.75 D in spherical equivalent
  • Median K values \< 40 D or \> 46 D
  • Topographical astigmatism \> 5 D
  • Abnormal corneal topography
  • Patients with previous corneal operations on the eye to be treated (e.g. LASIK, PRK, X-Linking; this does not include cataract operations)
  • Scarring or opacity of the cornea
  • Transplanted cornea
  • Connective tissue weaknesses
  • Keratectasia and other diseases of the cornea
  • Patients with wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
  • Patients regularly taking medicines that could influence the result of the treatment
  • Glaucoma or a risk of glaucoma
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Eye Clinic Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

FreeVis LASIK Center Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Augenklinik am Marienplatz AG & Co. KG

Munich, Bavaria, 80331, Germany

Location

Eye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein

Duisburg, North Rhine-Westphalia, 47169, Germany

Location

Related Publications (1)

  • Thomas BC, Fitting A, Khoramnia R, Rabsilber TM, Auffarth GU, Holzer MP. Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results. Br J Ophthalmol. 2016 Nov;100(11):1536-1541. doi: 10.1136/bjophthalmol-2015-307672. Epub 2016 Feb 22.

    PMID: 26903524DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 3, 2009

Study Start

December 1, 2009

Primary Completion

May 1, 2010

Study Completion

December 1, 2010

Last Updated

June 9, 2011

Record last verified: 2011-06

Locations

DE(4)