Clinical Trials Logo
  1. Home
  2. Dry Eye
  3. NCT02210793
  4. Details
NCT02210793 Clinical Trial

Dry Eye Evaluation After Transepithelial PRK

Dry Eye Clinical Trial

Official title:
Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02210793
Other study ID # ANH-1
Secondary ID ANH-TPRK1
Status Completed
Phase N/A
First received August 2, 2014
Last updated August 5, 2014
Start date April 2012
Est. completion date March 2013

Study information
Verified date August 2014
Source AL-Nour Eye Hospital
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik

Description:

Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria

- Myopia -1 to -6 diopters

- Astigmatism -0.5 to - 4 diopters

Exclusion Criteria:

- Pregnancy and lactation

- Keratoconus

- Previous refractive surgery

- Previous herpetic keratitis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Procedure:
• transepithelial PRK

• LASIK

Locations
Country Name City State
Egypt Al Nour Eye Hospital Giza

Sponsors (1)
Lead Sponsor Collaborator
AL-Nour Eye Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other healing time of epithelial defect epithelial defect the period of time in days needed for complete healing of the epithelial defect created during transepithelial PRK 2-5 days Yes
Primary qualitative assessment of dry eye syndrome Tear Break Up time is used as a qualitative measure of dry eye after surgery 6 months Yes
Primary quantitative of dry eye after surgery Schirmer test is used as a quantitative measure of dry eye after surgery 6 months Yes
Secondary haze haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system 6 months Yes
See also
  Status Clinical Trial Phase
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT04081610 - Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Phase 1
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT03418727 - Dry Eye Disease Study With Brimonidine Phase 2
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Recruiting NCT04527887 - Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) Phase 4
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT04553432 - Dry Eye OmniLenz Application of Omnigen Research Study Phase 4
Recruiting NCT04109170 - Dry Eye Evaluation System Based on Bioinformatics
Completed NCT04105842 - Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type N/A
Completed NCT05505292 - Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Phase 4
Completed NCT04668131 - Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease N/A
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A