Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

Myopia Clinical Trial

— SUPRACOR  

Official title:

A Prospective Study to Evaluate the Safety and Effectiveness of the Supracor Presbyopic Treatment Algorithm for Pseudophakic Eyes Using Lasik

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387360
• Other study ID #: 1107
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2011
• Last updated: May 19, 2015
• Start date: June 2011
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Technolas Perfect Vision GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Presbyopia

Intervention

Device:
• Supracor
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.

Locations

Country	Name	City	State
Philippines	Asian Eye Institute	Makati	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Country where clinical trial is conducted

Philippines, 

References & Publications (6)

Alió JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. Review. — View Citation

de Ortueta D. Is peripheral presbyLASIK a center-distance technique? J Refract Surg. 2008 Jun;24(6):561; author reply 562. — View Citation

Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. — View Citation

Ortiz D, Alió JL, Illueca C, Mas D, Sala E, Pérez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. — View Citation

Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alió 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. — View Citation

Pinelli R. More on peripheral PresbyLASIK as a center-distance technique. J Refract Surg. 2008 Sep;24(7):665. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better		6M	No
Secondary	The percentage of treated eyes within +/- 1.00D of target refraction		6M	No
Secondary	The percentage of treated eyes within +/- 0.50D of target refraction		6M	No
Secondary	The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better		6M	No
Secondary	Stability analysis: change of = 1D MRSE between two consecutive post-op visits		6M	No
Secondary	Preservation of VA: Loss of more than 2 lines in BCVA for distance vision		6M	Yes
Secondary	The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better		6M	Yes
Secondary	The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D		6M	Yes
Secondary	Cumulative incidence of AEs		6M	Yes
Secondary	Cumulative incidence subjective symptoms		6M	Yes