Conjunctival DiseasesNCT04340518
Conjunctival Rebound After Scleral Lens Wear
A study testing Scleral lens in people with Conjunctival Diseases, run by University of Houston at 1 site in United States.
Trial summary
Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Conjunctival Diseases
- What is being tested?
- Scleral lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 30 May 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal ocular surface without conjunctival or scleral disease
- Male or female
- 18 years of age and older prior to the initial visit
- A non-scleral lens wearer.
Who cannot join
- Individuals with anterior segment ocular pathology that may affect intraocular pressure and/or scleral/conjunctival health.
- Individuals with known adverse response to Fluress® ophthalmic drops
- Individuals with a history of habitual scleral lens wear
- If a usable baseline image is unable to be obtained at the initial visit due to small ocular surface area or eyelid anatomy
- Individuals currently taking any ocular medications that could affect intraocular pressure and/or scleral/conjunctival health
- Individuals who have any other conditions or situations which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston College of Optometry
Houston, Texas, 77204
About this study
Official title: Measuring the Recovery of the Conjunctival Tissue After 4 Days of Scleral Lens Wear
Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. The purpose of the study is to determine the amount of conjunctival compression caused by the devices and the length of time required for the shape to recover from compression.
Read the detailed description
The purpose of this study is to determine the interval required for the conjunctival tissue to return to its natural shape after scleral lens wear. All study visits will take place at the University of Houston College of Optometry (UHCO). Subjects will be recruited and fitted with scleral lenses to wear during the experimental days. Once the proper fit has been achieved, subjects will wear the scleral lens for 4 days total, returning after the 1st and 4th day of lens wear for approximately 2 hours of testing. The subjects will then return every 24-hours for measurements until their conjunctival shape has returned to the original shape. The testing will be done using the sMap scleral topographer, which measures the elevation of the conjunctiva. Testing is non-invasive although it requires instillation of Fluress eye drops, a sodium fluorescein dye with anesthetic that allows for imaging. The total number of visits is 9-14 and the length of visit ranges from 10 minutes to 2.5 hours.
- Conditions
- Conjunctival Diseases
- Being tested
- Scleral lens
- Keywords
- scleral lenses
- Medical subject headings
- Conjunctival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scleral lensDevice
Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use.
| Study group | Role | What they receive |
|---|---|---|
| Post-scleral lens wear | Experimental | Normal subjects without ocular diseased who have worn scleral lenses for at least 8 hours. Receives: Device: Scleral lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound at 120 minutes post-SL removal, Day 4
Conjunctival rebound amount at 120 minutes post-removal, Day 4
Measured: Measured 120-130 minutes post-SL removal, Day 4
Secondary outcomes (16)
Rebound at 120-hours post-SL discontinuation
Conjunctival rebound amount at 120 hours post-removal
Measured: Measured 115-125 hours post-SL removal
Rebound at 168-hours post-SL discontinuation
Conjunctival rebound amount at 168 hours post-removal
Measured: Measured 160-170 hours post-SL removal
Rebound at 144-hours post-SL discontinuation
Conjunctival rebound amount at 144 hours post-removal
Measured: Measured 140-150 hours post-SL removal
Rebound at 72-hours post-SL discontinuation
Conjunctival rebound amount at 72 hours post-removal
Measured: Measured 60-80 hours post-SL removal
Rebound at 90 minutes post-SL removal, Day 4
Conjunctival rebound amount at 90 minutes post-removal, Day 4
Measured: Measured 90-100 minutes post-SL removal, Day 4
Rebound at 90 minutes post-SL removal, Day 1
Conjunctival rebound amount at 90 minutes post-removal, Day 1
Measured: Measured 90-100 minutes post-SL removal, Day 1
Rebound at 60 minutes post-SL removal, Day 4
Conjunctival rebound amount at 60 minutes post-removal, Day 4
Measured: Measured 60-70 minutes post-SL removal, Day 4
Rebound at 30 minutes post-SL removal, Day 1
Conjunctival rebound amount at 30 minutes post-removal, Day 1
Measured: Measured 30-40 minutes post-SL removal, Day 1
Rebound at 24-hours post-SL discontinuation
Conjunctival rebound amount at 24 hours post-removal
Measured: Measured 20-30 hours post-SL removal
Rebound at 5 minutes post-SL removal, Day 1
Conjunctival rebound amount at 5 minutes post-removal, Day 1
Measured: Measured 5-10 minutes post-SL removal, Day 1
Rebound at 30 minutes post-SL removal, Day 4
Conjunctival rebound amount at 30 minutes post-removal, Day 4
Measured: Measured 30-40 minutes post-SL removal, Day 4
Rebound at 120 minutes post-SL removal, Day 1
Conjunctival rebound amount at 120 minutes post-removal, Day 1
Measured: Measured 120-130 minutes post-SL removal, Day 1
Rebound at 5 minutes post-SL removal, Day 4
Conjunctival rebound amount at 5 minutes post-removal, Day 4
Measured: Measured 5-10 minutes post-SL removal, Day 4
Rebound at 60 minutes post-SL removal, Day 1
Conjunctival rebound amount at 60 minutes post-removal, Day 1
Measured: Measured 60-70 minutes post-SL removal, Day 1
Rebound at 48-hours post-SL discontinuation
Conjunctival rebound amount at 48 hours post-removal
Measured: Measured 40-50 hours post-SL removal
Rebound at 96-hours post-SL discontinuation
Conjunctival rebound amount at 96 hours post-removal
Measured: Measured 90-100 hours post-SL removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Dec 2019
- Primary completion1 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctival DiseasesStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational study
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MKWalker, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340518
- Sponsor's protocol ID
- STUDY00001908
- Status last verified
- Jan 2021
- First submitted
- 3 Feb 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Recovery of the Conjunctival Tissue After 4 Days of Scleral Lens Wear
- ClinicalTrials.gov ID
- NCT04340518
- Acronym / sponsor ID
- STUDY00001908
- Conditions
- Conjunctival Diseases
- Keywords
- scleral lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 9 Apr 2020 (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.
Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. The purpose of the study is to determine the amount of conjunctival compression caused by the devices and the length of time required for the shape to recover from compression.
Detailed description
The purpose of this study is to determine the interval required for the conjunctival tissue to return to its natural shape after scleral lens wear. All study visits will take place at the University of Houston College of Optometry (UHCO). Subjects will be recruited and fitted with scleral lenses to wear during the experimental days. Once the proper fit has been achieved, subjects will wear the scleral lens for 4 days total, returning after the 1st and 4th day of lens wear for approximately 2 hours of testing. The subjects will then return every 24-hours for measurements until their conjunctival shape has returned to the original shape. The testing will be done using the sMap scleral topographer, which measures the elevation of the conjunctiva. Testing is non-invasive although it requires instillation of Fluress eye drops, a sodium fluorescein dye with anesthetic that allows for imaging. The total number of visits is 9-14 and the length of visit ranges from 10 minutes to 2.5 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational study
| Arm | Type | Receives |
|---|---|---|
| Post-scleral lens wear | Experimental | Device: Scleral lensNormal subjects without ocular diseased who have worn scleral lenses for at least 8 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normal ocular surface without conjunctival or scleral disease
- Male or female
- 18 years of age and older prior to the initial visit
- A non-scleral lens wearer.
Key exclusion criteria (6 listed)
- Individuals with anterior segment ocular pathology that may affect intraocular pressure and/or scleral/conjunctival health.
- Individuals with known adverse response to Fluress® ophthalmic drops
- Individuals with a history of habitual scleral lens wear
- If a usable baseline image is unable to be obtained at the initial visit due to small ocular surface area or eyelid anatomy
- Individuals currently taking any ocular medications that could affect intraocular pressure and/or scleral/conjunctival health
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 |
|---|---|---|
| Scleral lensScleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use. | Device | Post-scleral lens wear |
Primary outcome
Rebound at 120 minutes post-SL removal, Day 4
Time frame: Measured 120-130 minutes post-SL removal, Day 4
Conjunctival rebound amount at 120 minutes post-removal, Day 4
16 secondary outcomes
Rebound at 120-hours post-SL discontinuation
Time frame: Measured 115-125 hours post-SL removal
Rebound at 168-hours post-SL discontinuation
Time frame: Measured 160-170 hours post-SL removal
Rebound at 144-hours post-SL discontinuation
Time frame: Measured 140-150 hours post-SL removal
Rebound at 72-hours post-SL discontinuation
Time frame: Measured 60-80 hours post-SL removal
Rebound at 90 minutes post-SL removal, Day 4
Time frame: Measured 90-100 minutes post-SL removal, Day 4
Rebound at 90 minutes post-SL removal, Day 1
Time frame: Measured 90-100 minutes post-SL removal, Day 1
Rebound at 60 minutes post-SL removal, Day 4
Time frame: Measured 60-70 minutes post-SL removal, Day 4
Rebound at 30 minutes post-SL removal, Day 1
Time frame: Measured 30-40 minutes post-SL removal, Day 1
Rebound at 24-hours post-SL discontinuation
Time frame: Measured 20-30 hours post-SL removal
Rebound at 5 minutes post-SL removal, Day 1
Time frame: Measured 5-10 minutes post-SL removal, Day 1
Rebound at 30 minutes post-SL removal, Day 4
Time frame: Measured 30-40 minutes post-SL removal, Day 4
Rebound at 120 minutes post-SL removal, Day 1
Time frame: Measured 120-130 minutes post-SL removal, Day 1
Rebound at 5 minutes post-SL removal, Day 4
Time frame: Measured 5-10 minutes post-SL removal, Day 4
Rebound at 60 minutes post-SL removal, Day 1
Time frame: Measured 60-70 minutes post-SL removal, Day 1
Rebound at 48-hours post-SL discontinuation
Time frame: Measured 40-50 hours post-SL removal
Rebound at 96-hours post-SL discontinuation
Time frame: Measured 90-100 hours post-SL removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Conjunctival Diseases
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingPhase 2
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma
Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma, Gastric Mucosa-Associated Lymphoid Tissue Lymphoma
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 Scleral lens in people with Conjunctival Diseases, run by University of Houston at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jan 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rebound at 120 minutes post-SL removal, Day 4 (time frame: Measured 120-130 minutes post-SL removal, Day 4). 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 29 Jan 2021.