NCT06495112

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

June 26, 2024

Last Update Submit

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

OTHER
Other: Soft contact lens with lathe cut technique Lathe

Soft contact lens with cast molding technique

EXPERIMENTAL
Diagnostic Test: Soft contact lens with cast molding technique

Interventions

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.

Soft contact lens with lathe cut technique Lathe

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

Soft contact lens with cast molding technique

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Interventions

Contact Lenses, Hydrophilic

Intervention Hierarchy (Ancestors)

Contact LensesLensesOptical DevicesEquipment and Supplies

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

Locations