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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better | 6M |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Ang, M.D. | Asian Eye Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Eye Institute | Makati | Manila | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18811107 | Background | 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. | |
| 18581778 | 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. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D011305 | Presbyopia |
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better | 6M |
| The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D | 6M |
| Cumulative incidence of AEs | 6M |
| Cumulative incidence subjective symptoms | 6M |
| 19603619 | Result | 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. |
| 19537363 | 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. |
| 18494342 | 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. |
| 17269242 | 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. |