Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

NCT01387360 | Completed Phase 4 DMC

• 1 other identifier: 1107
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Hyperopia; Presbyopia

Keywords

Myopia; Hyperopia; Presbyopia; Pseudophakia; LASIK

Outcome Measures

Primary Outcomes (1)

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

  6M

Secondary Outcomes (9)

• The percentage of treated eyes within +/- 1.00D of target refraction

  6M

• The percentage of treated eyes within +/- 0.50D of target refraction

  6M

• The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better

  6M

• Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits

  6M

• Preservation of VA: Loss of more than 2 lines in BCVA for distance vision

  6M

Study Arms (1)

Supracor

EXPERIMENTAL

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.

Device: Supracor

Interventions

Supracor DEVICE

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.

Also known as: PresbyLASIK, Multifocal Ablation

Supracor

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (1)

Asian Eye Institute

Makati, Manila, Philippines

Location

Related Publications (6)

• 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.

  PMID: 18811107 BACKGROUND

• 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.

  PMID: 18581778 BACKGROUND

• 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.

  PMID: 19603619 RESULT

• 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.

  PMID: 19537363 RESULT

• 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.

  PMID: 18494342 RESULT

• 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.

  PMID: 17269242 RESULT

MeSH Terms

Conditions

Myopia; Hyperopia; Presbyopia; Pseudophakia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Ang, M.D.

  Asian Eye Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 4, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

PH (1)