Ocular Surface DiseaseNCT06495112
Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity
A study testing Soft contact lens with lathe cut technique Lathe and Soft contact lens with cast molding technique in people with Ocular Surface Disease, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- Soft contact lens with lathe cut technique Lathe and Soft contact lens with cast molding technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients who have never used contact lenses
- Age of participants would be 15 to 35 years
- Patients free of any ocular pathology
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society
Lahore, Punjab Province
About this study
"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.
Read the 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.
- Conditions
- Ocular Surface Disease
- Being tested
- Soft contact lens with lathe cut technique Lathe, Soft contact lens with cast molding technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft contact lens with lathe cut technique LatheOther
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 cast molding techniqueDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Soft contact lens with lathe cut technique Lathe | Other | Not described Receives: Other: Soft contact lens with lathe cut technique Lathe |
| Soft contact lens with cast molding technique | Experimental | Not described Receives: Diagnostic Test: Soft contact lens with cast molding technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495112
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/730
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity
- ClinicalTrials.gov ID
- NCT06495112
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/730
- Conditions
- Ocular Surface Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who have never used contact lenses
- Age of participants would be 15 to 35 years
- Patients free of any ocular pathology
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft contact lens with lathe cut technique Latheathe 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. | Other | Soft contact lens with lathe cut technique Lathe |
| Soft contact lens with cast molding techniqueParticipants 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 | Diagnostic test | Soft contact lens with cast molding technique |
Primary outcome
Corneal epithelial integrity
Time frame: 12 Months
This involves assessing the health and integrity of the outermost layer of the cornea, which can be done through optical coherence tomography (OCT)
Ocular surface symptoms
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft contact lens with lathe cut technique Lathe and Soft contact lens with cast molding technique in people with Ocular Surface Disease, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal epithelial integrity (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.