Comparison of efficacy of two types of contact lenses on reducing pain and discomfort of patients after photorefractive keratectomy

Comparison of efficacy of two types of silicone hydrogel contact lenses Lotrafilcon B and Balafilcon A after photorefractive keratectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013122413567N8

Enrollment

120

Registered

2014-10-10

Start date

2014-04-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myopia, hyperopia. mild or no visual impairment, binocular

Interventions

Intervention 1: Intervention group 1: consists of one eye of each patient which is fitted with Lotrafilcon B silicone hydrogel contact lens (Air Optix®AQUA, Ciba Vision, Duluth, GA, USA) by a surgeon

Treatment - Other

Treatment - Drugs

Intervention group 1: consists of one eye of each patient which is fitted with Lotrafilcon B silicone hydrogel contact lens (Air Optix®AQUA, Ciba Vision, Duluth, GA, USA) by a surgeon who is aware of

Intervention group 2: consists of one eye of each patient which is fitted with Balafilcon A silicone hydrogel contact lens (PureVision™ Bausch & Lomb, Rochester, NY, USA) by a surgeon who is aware of

Eligibility

Sex/Gender

All

Age

19 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age 19 to 40 years old; refraction stability of at least 1 year; myopia of 8 diopter or less/astigmatism of 6 diopter or less; minimum corneal thickness of 480 micrometer in ultrasound pachymetry; minimum residual stromal thickness of 420 micrometer; corrected distant visual acuity equal or more than 20/20 Exclusion criteria: Ocular diseases such as cataract and glaucoma; corrected distant visual acuity of less than 20/20; diseases that could delay recovery such as diabetes mellitus, collagen vascular diseases, autoimmune diseases, herpetic eye infection and immune deficiency; history of colloid formation following previous surgeries

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Epiphora. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Foregin body sensation. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Blurred vision. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Photophobia. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.	—

Measure

Time frame

Pain. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Epiphora. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Foregin body sensation. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Blurred vision. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.;Photophobia. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.

—

Secondary

Measure	Time frame
Satisfaction. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Mohammadpour

Tehran University of Medical Sciences

mohammadpour_m@sina.tums.ac.ir+98 21 5542 1006

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026