Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity
1 other identifier
interventional
69
1 country
1
Brief Summary
"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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJuly 10, 2024
July 1, 2024
6 months
June 26, 2024
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Soft contact lens with lathe cut technique Lathe
OTHERSoft contact lens with cast molding technique
EXPERIMENTALInterventions
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.
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
Eligibility Criteria
You may qualify if:
- Patients who have never used contact lenses
- Age of participants would be 15 to 35 years
- Patients free of any ocular pathology
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society
Lahore, Punjab Province, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 10, 2024
Study Start
November 1, 2023
Primary Completion
May 1, 2024
Study Completion
September 30, 2024
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share