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Photorefractive keratectomy (PRK) involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Our study is focusing on comparing the outcomes of the conventional 2 step trans-epithelial PTK-PRK to the new single step trans-epithelial PRK (StreamLight PRK, Alcon lab, TX, USA).
Photorefractive keratectomy (PRK) is nowadays one of the commonest refractive procedures in laser vision correction (LVC). PRK differs from laser in situ keratomileusis (LASIK) in that it's a flapless procedure involving the removal of corneal epithelium with different techniques including manual removal , alcohol assisted removal or excimer laser assisted removal with phototherapeutic keratectomy (PTK). Mechanical or alcohol assisted debridement of the epithelium may lead to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK).
Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile.
Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted.
The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK (StreamLight Technology) versus the routine 2 step PTK-PRK in terms of postoperative vision, epithelial healing, pain scoring and haze evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients planned to undergo conventional 2 step trans-epithelial PTK-PRK | Active Comparator | Patients planned to undergo:
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| Patients planned to undergo the new single step trans-epithelial (StreamLight) PRK. | Active Comparator | Patients planned to undergo: Epithelial removal and Excimer wavefront optimized Laser Vision Correction in a single step using the new StreamLight Technology. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photorefractive keratectomy (PRK) | Procedure | Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism. |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected distant visual acuity (UDVA) | Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation | 6 months |
| Postoperative Refraction (Spherical equivalent) | Measured by Topcon Auto-Keratorefractometer | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Epithelial healing duration | Time for the epithelium to heal reported in days after PRK procudre | 2 weeks |
| Postoperative pain | Verbal Rating Scale(a series of words commonly used to describe pain (0: no pain, 1: mild pain, 2: moderate pain, 3: severe pain, 4: disabling pain) |
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Inclusion Criteria: Candidates for Laser vision correction (LVC) with
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TIBA eye center | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26871764 | Background | Kaluzny BJ, Cieslinska I, Mosquera SA, Verma S. Single-Step Transepithelial PRK vs Alcohol-Assisted PRK in Myopia and Compound Myopic Astigmatism Correction. Medicine (Baltimore). 2016 Feb;95(6):e1993. doi: 10.1097/MD.0000000000001993. | |
| 35864163 | Derived | Abdel-Radi M, Shehata M, Mostafa MM, Aly MOM. Transepithelial photorefractive keratectomy: a prospective randomized comparative study between the two-step and the single-step techniques. Eye (Lond). 2023 Jun;37(8):1545-1552. doi: 10.1038/s41433-022-02174-4. Epub 2022 Jul 21. |
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| ID | Term |
|---|---|
| D018903 | Photorefractive Keratectomy |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
| 1 week |
| Postoperative Haze | Corneal Haze scoring using slit lamp bio-microscopy according to Fantes scoring system: 0: No haze, completely clear cornea 0.5: Trace haze seen with careful oblique illumination
| 3 months |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |