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By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.
This study will help us to answer 2 questions:
LASIK is a surgical technique where the cornea is reshaped using a laser to provide visual correction. Typically, this procedure will only correct your long distance vision requiring the use of supplementary spectacles for reading and near vision.
The Technolas 217z Excimer Laser used to deliver the treatment is approved for use in the European Community for both treatment versions to correct separately the near vision and the distance vision for cases which need one or the other correction.
By using a new software two consecutive treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.
This study will help us to answer 2 questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myopic Treatment Arm | Experimental | Patients treated in this arm will have preoperative measurements that indicate a myopic condition of the eye in conjunction with a presbyopic condition |
|
| Hyperopic Treatment Arm | Experimental | Patients treated in this arm will have preoperative measurements that indicate a hyperopic condition of the eye in conjunction with a presbyopic condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supracor | Procedure | All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components. The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases. In addition to the treatment for the distance vision a central ablation component will be added to address the near vision. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of treated patients with an uncorrected monocular high contrast Near VA of 20/40 or better | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of treated eyes within +/- 1.00D of target refraction | 6 Months | |
| The percentage of treated eyes within +/- 0.50D of target refraction | 6 Months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Barragan, M.D. | Laser Ocular Hidalgo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Ocular Hidalgo | Monterrey | N.l. | 64060 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16500528 | Background | Telandro AP, Steile J 3rd. Presbyopia: perspective on the reality of pseudoaccommodation with LASIK. Ophthalmol Clin North Am. 2006 Mar;19(1):45-69, vi. doi: 10.1016/j.ohc.2005.10.006. | |
| 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. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
|
| The percentage of treated eyes with a monocular uncorrected high contrast distance VA of 20/40 or better |
| 6 Months |
| Preservation of VA: Loss of more than 2 lines in monocular BCVA for distance vision | 6 Months |
| The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D | 6 Months |
| 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. |
| 18500082 | Result | Illueca C, Alio JL, Mas D, Ortiz D, Perez J, Espinosa J, Esperanza S. Pseudoaccommodation and visual acuity with Technovision presbyLASIK and a theoretical simulated Array multifocal intraocular lens. J Refract Surg. 2008 Apr;24(4):344-9. doi: 10.3928/1081597X-20080401-05. |
| 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. |
| 16722483 | Result | Alio JL, Chaubard JJ, Caliz A, Sala E, Patel S. Correction of presbyopia by technovision central multifocal LASIK (presbyLASIK). J Refract Surg. 2006 May;22(5):453-60. doi: 10.3928/1081-597X-20060501-06. |
| 16850290 | Result | Becker KA, Jaksche A, Holz FG. [PresbyLASIK: treatment approaches with the excimer laser]. Ophthalmologe. 2006 Aug;103(8):667-72. doi: 10.1007/s00347-006-1391-y. German. |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |