Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity

"Comparison between Lathe Cut versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity" investigates the impact of two different manufacturing methods on the health and integrity of the ocular surface.

Study Overview

• Status: Active, not recruiting
• Conditions: Ocular Surface Disease
• Intervention / Treatment: Other: Soft contact lens with lathe cut technique Lathe; Diagnostic test: Soft contact lens with cast molding technique

Detailed Description

The study aims to determine which technique, lathe cutting or cast molding, produces soft contact lenses that are more biocompatible and less likely to cause adverse effects on the eye. The findings from our research could have significant implications for contact lens wearers and manufacturers, guiding the production of lenses that promote better ocular health and enhance wearer comfort. Ultimately, this research contributes valuable knowledge to optometry and ocular surface disease management.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients who have never used contact lenses
• Age of participants would be 15 to 35 years
• Patients free of any ocular pathology

Exclusion Criteria:

• Patients having astigmatism of more than 0.75DC
• Subjects with a previous history of ocular surgery, eye pathology, or systemic disease.
• Patients with abysmal compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Soft contact lens with lathe cut technique Lathe	Other: Soft contact lens with lathe cut technique Lathe; athe cut technique Lathe cutting involves shaping a solid block of lens material into the desired form using precision machinery. This method allows for customized lens designs but may result in a less smooth surface compared to cast molding. Cast molding, on the other hand, uses a liquid monomer that is cured in a mold to form the lens. This technique typically results in a smoother and more uniform lens surface.
Experimental: Soft contact lens with cast molding technique	Diagnostic test: Soft contact lens with cast molding technique; Participants in this arm would receive Cast molding soft contact lenses and would wear them according to the study protocol, also likely for a specified duration.The cast molding technique for soft contact lenses involves creating lenses by polymerizing a liquid monomer mixture within a mold that forms the desired lens shape. Here's a brief overview of the steps involved in the cast molding process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal epithelial integrity	This involves assessing the health and integrity of the outermost layer of the cornea, which can be done through optical coherence tomography (OCT)	12 Months
Ocular surface symptoms	Utilizing standardized questionnaires or scales to assess symptoms such as dryness, discomfort, or irritation experienced by the subjects wearing the different types of soft contact lenses.	12 months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MSRSW/Batch-Fall22/730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No