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Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes (SUPRACOR)

Primary Purpose

Myopia, Hyperopia, Presbyopia

Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Supracor
Sponsored by
Technolas Perfect Vision GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, Hyperopia, Presbyopia, Pseudophakia, LASIK

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must be at least 45 years old
  • Subjects must read, understand, and sign an Informed Consent Form (ICF).
  • Subjects must be willing and able to return for scheduled follow-up examinations through 6 months after surgery.
  • Subjects must have undergone previous uncomplicated cataract surgery with monofocal IOL implant in the study eye at least 3 months prior to study enrollment.
  • Subjects must have up to +/- 2.0 (D) of absolute spherical myopia or hyperopia (not spherical equivalent), with up to +/- 2.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent must be no more than +/- 2.0 D.
  • Subjects who have be screened successfully for acceptance of the SUPRACOR simulation

Exclusion Criteria:

  • Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining corneal thickness below the flap postoperatively.
  • Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan (e.G. Keratoconus).

Sites / Locations

  • Asian Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supracor

Arm Description

Study arm will consist of patients who have undergone previous cataract surgery with implantation of a monofocal IOL. The Supracor procedure will be performed on the non-dominant pseudophakic eye of these patients.

Outcomes

Primary Outcome Measures

The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better

Secondary Outcome Measures

The percentage of treated eyes within +/- 1.00D of target refraction
The percentage of treated eyes within +/- 0.50D of target refraction
The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better
Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits
Preservation of VA: Loss of more than 2 lines in BCVA for distance vision
The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better
The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D
Cumulative incidence of AEs
Cumulative incidence subjective symptoms

Full Information

First Posted
June 28, 2011
Last Updated
May 19, 2015
Sponsor
Technolas Perfect Vision GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01387360
Brief Title
Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes
Acronym
SUPRACOR
Official Title
A Prospective Study to Evaluate the Safety and Effectiveness of the Supracor Presbyopic Treatment Algorithm for Pseudophakic Eyes Using Lasik
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2013 (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
Yes

5. Study Description

Brief Summary
This clinical study has been planned to determine the effectiveness of a special laser treatment intended to correct both near and distance vision in patients who have undergone previous cataract surgery.
Detailed Description
This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACOR presbyopic excimer laser treatment algorithm for near myopic and near hyperopic indications, with or without astigmatism, when performed on the cornea of pseudophakic eyes implanted with a monofocal IOL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Presbyopia
Keywords
Myopia, Hyperopia, Presbyopia, Pseudophakia, LASIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supracor
Arm Type
Experimental
Arm Description
Study arm will consist of patients who have undergone previous cataract surgery with implantation of a monofocal IOL. The Supracor procedure will be performed on the non-dominant pseudophakic eye of these patients.
Intervention Type
Device
Intervention Name(s)
Supracor
Other Intervention Name(s)
PresbyLASIK, Multifocal Ablation
Intervention Description
The presbyopic treatment consists of a standard treatment for distance vision and the procedure known as SUPRACOR addition to correct near vision. The SUPRACOR addition provides a multifocal ablation with a central near addition with an aberration controlled transition zone towards the periphery, thereby allowing good focus over a range of object distances.
Primary Outcome Measure Information:
Title
The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better
Time Frame
6M
Secondary Outcome Measure Information:
Title
The percentage of treated eyes within +/- 1.00D of target refraction
Time Frame
6M
Title
The percentage of treated eyes within +/- 0.50D of target refraction
Time Frame
6M
Title
The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better
Time Frame
6M
Title
Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits
Time Frame
6M
Title
Preservation of VA: Loss of more than 2 lines in BCVA for distance vision
Time Frame
6M
Title
The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better
Time Frame
6M
Title
The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D
Time Frame
6M
Title
Cumulative incidence of AEs
Time Frame
6M
Title
Cumulative incidence subjective symptoms
Time Frame
6M

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must be at least 45 years old Subjects must read, understand, and sign an Informed Consent Form (ICF). Subjects must be willing and able to return for scheduled follow-up examinations through 6 months after surgery. Subjects must have undergone previous uncomplicated cataract surgery with monofocal IOL implant in the study eye at least 3 months prior to study enrollment. Subjects must have up to +/- 2.0 (D) of absolute spherical myopia or hyperopia (not spherical equivalent), with up to +/- 2.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent must be no more than +/- 2.0 D. Subjects who have be screened successfully for acceptance of the SUPRACOR simulation Exclusion Criteria: Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining corneal thickness below the flap postoperatively. Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan (e.G. Keratoconus).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ang, M.D.
Organizational Affiliation
Asian Eye Institute
Official's Role
Study Director
Facility Information:
Facility Name
Asian Eye Institute
City
Makati
State/Province
Manila
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
18811107
Citation
Pinelli R. More on peripheral PresbyLASIK as a center-distance technique. J Refract Surg. 2008 Sep;24(7):665. doi: 10.3928/1081597X-20080901-04. No abstract available.
Results Reference
background
PubMed Identifier
18581778
Citation
de Ortueta D. Is peripheral presbyLASIK a center-distance technique? J Refract Surg. 2008 Jun;24(6):561; author reply 562. doi: 10.3928/1081597X-20080601-01. No abstract available.
Results Reference
background
PubMed Identifier
19603619
Citation
Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. doi: 10.3928/1081597X-20090512-05.
Results Reference
result
PubMed Identifier
19537363
Citation
Alio JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. doi: 10.1097/icu.0b013e32832a7ded.
Results Reference
result
PubMed Identifier
18494342
Citation
Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alio JL. Correction of presbyopia in hyperopia with a center-distance, paracentral-near technique using the Technolas 217z platform. J Refract Surg. 2008 May;24(5):494-500. doi: 10.3928/1081597X-20080501-07.
Results Reference
result
PubMed Identifier
17269242
Citation
Ortiz D, Alio JL, Illueca C, Mas D, Sala E, Perez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. doi: 10.3928/1081-597X-20070101-07.
Results Reference
result

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Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

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