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Ocular HypertensionNCT03926975

The Effect of a Scleral Lens on the Anterior Chamber Depth and Minimum Rim Width

A study testing Scleral Lens and No lens in people with Ocular Hypertension, run by University of Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the use of two instruments to measure changes in two ocular structures: 1) the anterior chamber depth (ACD) - measured using low coherence optical biometry, and 2) minimum rim width of the optic nerve head (MRW) - measured using optical coherence tomography. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Ocular Hypertension
What is being tested?
Scleral Lens and No lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
1 Jun 2018to 30 Aug 2019
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • young, normal individuals

Who cannot join

  • IOP > 20mm in either eye, and h/o ocular hypertension, glaucoma, or ocular surgery that can affect IOP.
  • h/o scleral lens wear or current scleral lens wear

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University Eye Institute

    Houston, Texas, 77204

Other trials in United States

About this study

The purpose of this study is to evaluate the use of two instruments to measure changes in two ocular structures: 1) the anterior chamber depth (ACD) - measured using low coherence optical biometry, and 2) minimum rim width of the optic nerve head (MRW) - measured using optical coherence tomography. Changes in these ocular structures indicate fluctuations in intraocular pressure (IOP) and will be measured during scleral contact lens (SGP) wear to determine if SGP wear influences IOP. We hypothesize that a scleral lens increases the intraocular pressure (IOP) during active wear and that the ACD and MRW will also change.

Read the detailed description

Contact lenses are often used to correct vision blur. The most common types of contact lenses include those referred to as 'soft' and 'rigid'. Visual acuity through rigid lenses often surpasses that of soft lenses. Historically, these lenses have been small in diameter, and hence patients also felt discomfort when wearing the lenses. Scleral lenses are relatively new, customized devices that have gained popularity with patients and practitioners in the past 5-10 years, because they are more comfortable and provide more stable vision than the small diameter rigid contact lenses. However, relatively little is known about the physiologic response of the eye to the scleral lens, or the long-term effects of their use, since they are such a new modality.

Maintaining the IOP within the eye is imperative to prevent damage to ocular tissue, which can occur in glaucoma. Given the landing of scleral lens overlying the sclera and ciliary body, which assist in modulating the transport of fluid in the eye, there is a potential for these lenses to impinge on fluid drainage which could lead to increases of IOP during scleral lens wear. The placement of the lens creates an obstacle in evaluating IOP while the lens is actually on the eye (covering the cornea), and since increases in IOP may only occur during lens wear, which is removed when determining clinical IOP measurements, it is difficult to monitor IOP during scleral lens wear with traditional IOP instrumentation (ie. iCare, Goldman, etc).

Optical coherence tomography is a non-invasive imaging technology that has revolutionized how the retina and optic nerve are clinically evaluated. The optic nerve head is typically assessed using radial scans, from which the minimal distance from the Bruch's membrane opening to the inner limiting lamina is quantified as the minimum rim width (MRW). With changes in IOP, the MRW is known to also change in thickness. Many studies are investigating the MRW changes during IOP fluctuations, with studies finding a decrease in MRW during acute IOP increase. In this project, MRW will be used to indirectly assess changes in IOP by measuring the MRW periodically during active scleral lens wear.

In addition, we are incorporating low coherence optical biometry (Lenstar) to evaluate the effect of the scleral lens pressure on the anterior chamber. Using the Lenstar, corneal thickness, anterior chamber depth (ACD), lens thickness and vitreous chamber depth can be quantified. In this project, ACD will be used to indirectly evaluate changes in the pressure within the anterior chamber. The assumption is that the ACD will change based on changes in pressure in the scleral lens tear reservoir.

This study will add to the knowledge of how the scleral lens affects the dynamic pressure system of the eye. Based on the implications for disease with chronic increases and fluctuations in IOP, this is important information to understand with the scleral lens, a relatively new refractive treatment modality.

Being tested
Scleral Lens, No lens
Medical subject headings
Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scleral LensDevice

    The contact lens will be worn on one eye.

  • No lensOther

    No lens worn on the contralateral control eye

Study groups in NCT03926975
Study groupRoleWhat they receive
Experimental: Scleral LensExperimentalOne eye will be randomly selected to wear a scleral lens for a 6-hour testing period.
Receives: Device: Scleral Lens
Control: no lensActive comparatorThe contralateral eye will not wear a lens.
Receives: Other: No lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in minimum rim width from baseline to 6-hours SL wear

    The Bruch's membrane opening to the inner limiting lamina (termed the minimum rim width) will be measured at the optic nerve head.

    Measured: at baseline, after 2-hours lens wear, and after 6-hours lens wear

Secondary outcomes (2)
  1. Intraocular pressure (IOP)

    IOP will be measured using the Diaton and iCare tonometers

    Measured: at baseline, after 2-hours lens wear, and after 6-hours lens wear

  2. Anterior Chamber Depth (ACD)

    ACD will be measured with the Lenstar A-scan

    Measured: at baseline, after 2-hours lens wear, and after 6-hours lens wear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2019
  2. Study start1 Jun 2018
  3. Primary completion15 Jun 2019
  4. Study completion30 Aug 2019

Resources

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
Basic science
Allocation
Randomised
Intervention model
Single group
Model description
Subjects are all non-scleral lens wearers. One eye (test) will be selected to wear a scleral lens, and the contralateral eye (control) will not wear any lens.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926975
Sponsor's protocol ID
STUDY00000747
Status last verified
Jan 2021
First submitted
18 Apr 2019
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Walker MK, Pardon LP, Redfern R, Patel N. IOP and Optic Nerve Head Morphology during Scleral Lens Wear. Optom Vis Sci. 2020 Sep;97(9):661-668. doi: 10.1097/OPX.0000000000001567.

    PubMed 32932395

Questions about this trial

What is this clinical trial studying?

A study testing Scleral Lens and No lens in people with Ocular Hypertension, 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 1 inclusion and 2 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?

Change in minimum rim width from baseline to 6-hours SL wear (time frame: at baseline, after 2-hours lens wear, and after 6-hours lens wear). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926975, which also lists 1 linked publication.

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.

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