Clinical trial NCT01387360: Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Hyperopia
Presbyopia
Keywords: Myopia
Hyperopia
Presbyopia
Pseudophakia
LASIK
Lead sponsor: Technolas Perfect Vision GmbH
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 33
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better
timeFrame: 6M
Secondary outcomes:
measure: The percentage of treated eyes within +/- 1.00D of target refraction
timeFrame: 6M
measure: The percentage of treated eyes within +/- 0.50D of target refraction
timeFrame: 6M
measure: The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better
timeFrame: 6M
measure: Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits
timeFrame: 6M
measure: Preservation of VA: Loss of more than 2 lines in BCVA for distance vision
timeFrame: 6M
measure: The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better
timeFrame: 6M
measure: The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D
timeFrame: 6M
measure: Cumulative incidence of AEs
timeFrame: 6M
measure: Cumulative incidence subjective symptoms
timeFrame: 6M
Other outcomes:
Locations:
city: Makati
country: Philippines
facility: Asian Eye Institute
state: Manila
Study officials:
affiliation: Asian Eye Institute
name: Robert Ang, M.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.