Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer
Phase: NA
Conditions: Contact Lens Adaptation
Sponsor: University of Alabama at Birmingham

 
Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer  
 
 
Study Protocol and Statistical Analysis Plan  
 
NCT04583579  
 
December 1, 2020  
 
Andrew Pucker, OD, PhD, Principal Investigator University of Alabama at Birmingham 
Birmingham, AL 35294 
 
 

 
INTRODUCTION & RATIONALE  
 
Scleral lens (SL) prescribing has dramatically increased over the past few years likely because of the advent of 
better SL designs, better materials, and greater awareness of the technology.1 SL market growth has also likely 
increased because SLs were once reserved for patients with complex ocular surface diseases, though advances 
with SL technologies have allowed SL fitting to include patients with dry eye and even patients who have 
relatively uncomplicated refractive errors.1, 2 While SLs are maintained and cared for much like soft contact 
lenses (e.g., they require a contact lens care system), SL wearers also need help with applying their lenses. 
Patients specifically are advised by their care provider to insert their SLs with their fingers (tripod method), a 
DMV inserter with an open or closed end (hole potentially aides in vision), or a specialized o-ring that is balanced 
on a finger. Our clinic also utilizes a tea light candle with a DMV inserter attached to the top of it when patients 
have mobility issues. While work from this investigator’s study group has found that 54% of patients prefer DMV 
inserters for applying their SLs as compared to the above other options, these preliminary data were obtained 
through a cross-sectional electronic survey from subjects who completed their SL fitting up to two years ago. 
Therefore, the goal of this proposal is to conduct a randomized controlled study aimed at learning the best 
method for applying SLs and factors associated with successfully completing SL application and removal training. 
These data are needed because it will help practitioners with patient education and because it may increase the 
likelihood that patients will be successful with SLs.  
 
SPECIFIC AIMS 
 
This study will address the following specific aims and associated hypotheses:  
 
1. Determine a neophyte SL wearers’ preferred scleral lens application method. Hypothesis 1: There will 
be no statistical difference in the SL patient’s preference among the five application methods (DMV 
inserter with an open or closed end, three fingers, o-ring, tea light candle) after the initial training visit.  
 
2. Determine factors that influence the amount of time it takes for a neophyte SL wearer to be able to 
successfully apply and remove their SLs. Hypothesis 2: Past contact lens experience, SL diameter, 
uncorrected visual acuity, and subject age will all influence the total time needed to complete all five 
application methods successfully.   
 
STUDY DESIGN  
 
Subjects and Recruitment  
 
This study will be conducted at the UAB School of Optometry (Birmingham, AL, USA). Subjects will be recruited 
by word of mouth during regular clinical care. Adult (>18 years) subjects will be recruited for this study. 
Subjects will be excluded if they have past experience or advanced knowledge of SLs, a physical or cognitive 
condition that may prevent them from successfully wearing SLs (e.g., stroke), or if they are currently 
participating in another clinical trial. Since there is limited data on this topic and since the literature lacks a 
method for calculating a sample size for a five-way comparison, a true sample size calculation is not possible 
for this project. Since this study is preliminary in nature, 25 subjects will be recruited to gain an initial 
understanding of how subjects prefer to apply SLs. Five additional subjects will be recruited to account for 
screen failures (total of 30 subjects).  
 
Clinical Protocol  
 

 
Visit 1: Baseline Visit  
 
1. Subject History, Eligibility, Informed Consent: Subjects will be asked to complete an IRB-approved screening 
survey to verify that they are still eligible for the study. Eligible subjects will be enrolled, consented, and 
requested to sign a privacy document. All relevant subject history will be gathered via a questionnaire developed 
by the investigators that asks about the patient’s past contact lens and ocular disease history. Non-eligible 
subjects will be dismissed at this time.  
 
2. Questionnaires: All subjects will be asked to complete the Standardized Patient Evaluation of Eye Dryness 
(SPEED) questionnaire because it is a validated dry eye symptoms questionnaire that asks about the most 
common dry eye symptoms.3 Subjects will also be asked to complete the Contact Lens Dry Eye Questionnaire 
(CLDEQ)-8 because it is a validated instrument that asks about contact lens comfort and coping mechanisms. 
The Orthokeratology and Contact Lens Quality of Life Questionnaire (OCL-QoL) will also be administered 
because it assesses the patient’s visual quality of life.4  
 
3. Visual Acuity: Uncorrected and habitually-corrected visual acuity will be measured with a high-contrast 
Snellen chart. If the patient is unable to read the 20/40 letters, the investigator will pinhole over the patient’s 
unaided or presenting refractive error correction to determine the subject’s visual potential.  
 
4. Manifest Refraction: The investigator will determine the subject’s refractive error with a phoropter, and 
binocular balance will be performed if best-corrected visual acuity is equal in between eyes. Visual acuity will 
be recorded as described above in step 3.  
 
5. Slit-Lamp Biomicroscopy: The investigator will use a slit-lamp biomicroscope to document normal and/or 
remarkable findings of the anterior eye structures: eyelids, conjunctiva, and cornea.  
 
6. Topography: Topography will be performed with the SMap3D. The device’s standard procedure will be 
followed, and parameters from this measurement will be sent to the manufacture to help determine the 
patient’s first SL.   
 
7: Scleral Lens Fitting: The Europa lens will be fit based upon the manufacturer’s guidelines with their fitting 
set. A slit-lamp biomicroscope evaluation will be performed on the trial lens to estimate the central corneal 
clearance and overall fit after 30 minutes of settling. SL information will be provided to the manufacturer to 
help determine the patient’s first SL.  
 
Visit 2: Dispense Visit  
 
1. Visual Acuity: Visual acuity with habitual correction will be measured with a high-contrast Snellen chart. If 
the patient is unable to read the 20/40 letters, the investigator will pinhole over the patient’s unaided or 
presenting refractive error correction to determine the subject’s visual potential.  
 
2. Slit-Lamp Biomicroscopy: The investigator will use a slit-lamp biomicroscope to document normal and/or 
remarkable findings of the anterior eye structures: eyelids, conjunctiva, and cornea.  
 
3. Lens Dispense: The investigator will orient the patient and apply the ordered SLs to each eye. The investigator 
will use a slit-lamp biomicroscope and OCT to evaluate the SLs after 30 minutes of lens settling. If the lenses fit 
acceptably, the patient will undergo application and removal training (based on the randomization order 

 
determined during step 4). If the lenses do not fit acceptably, new lenses will be ordered, and the subject will 
be scheduled for a follow up visit for after the study lenses arrive.   
 
4. Randomization: The investigator will access the online randomization tool (REDCap) and determine the order 
by which subjects will apply their lenses (DMV inserter with an open end (A), DMV inserter with a closed end (B), 
three fingers (C), o-ring (D), tea light candle (E)). Right eyes will undergo the application protocol; however, if 
the patient only needs a SL for their left eye, the left eye will undergo the protocol. Hand and eye dominance 
will be recorded. Subjects will then be instructed via training videos created by the investigators on how to do 
each application method. Each training video will be shown before starting each application method, and the 
examiner will answer the subject’s questions prior to attempting the application method. The same investigator 
will teach each subject. Subjects will be timed during each application; however, time recording will not be made 
obvious. After a subject successfully completes an application method once for the designated eye, they will be 
asked to do the subsequent method. If a subject is unsuccessful with a method and declines to continue that 
method after being encouraged, the time will be recorded, and they will be allowed to try the next method. The 
subject will be allowed up to 15 minutes to complete each method. If the subject is unable to complete the 
method within that time frame, they will be instructed to do the next method to help avoid fatigue. If a patient 
stops a procedure before completing an application, this event will be recorded. Patients will be encouraged to 
try all five methods on the same day; however, subjects will be allowed to come back on a subsequent day if 
they get tired. Subjects will be asked to rank the ease of application for each method from easiest to most 
challenging after trying each method. If a subject needs a SL for their contralateral eye, they will be taught how 
to apply this lens after they have completed the training for their designated eye. If a subject is able to apply 
the lenses, they will be asked to remove the lenses as well. Only one removal method will be used (small 
plunger), and the removal time will also be timed for each method (timed separately from application).  
 
5. SL Release: After a subject completes the application and removal process, they will be given everything they 
need to wear the lenses (non-preserved saline (Adipack), application devices). They will also be given a trial 
bottle of Boston Simplus (contact lens care system), and they will be allowed to try their lenses for about one 
week. Subjects will be instructed to use their preferred application method at home.  
 
6. SL Adaptation Form: Subjects will be given a take-home diary to complete during the one-week trial period. 
This diary will ask the subject about their experience with applying and removing their lenses, their comfort, 
and their perception of the SLs.   
 
Visit 3: Outcome Visit  
 
1. Visual Acuity: Visual acuity with SLs will be measured with a high-contrast Snellen chart. If the patient is 
unable to read the 20/40 letters, the investigator will pinhole over the patient’s unaided or presenting refractive 
error correction to determine the subject’s visual potential.  
 
2. SL Evaluation: The investigator will use a slit-lamp biomicroscope to evaluate the SLs. The subject will be 
required to have worn their lenses for at least two hours before the study visit. Anterior segment optical 
coherence tomography (OCT) will also be performed to obtain an accurate central corneal clearance 
measurement.  
 
3. Questionnaires: All subjects will be asked to complete the SPEED, CLDEQ-8, and OCL-QoL questionnaires at 
the final SL fitting visit. They will also be asked to complete an investigator-designed questionnaire to 
understand the initial SL wearing experience.  
 

 
4. Study Completion: The subject will be compensated, and the subject will be exited from the study, but they 
will be encouraged to continue their SL care with their provider.  
 
Data Collection and Analysis 
 
Data collection will be performed with Research Electronic Data Capture (REDCap). Data will be analyzed with 
STATA 16 (StataCorp LLC; College Station, TX). Means and standard deviations will be used to understand 
general data trends. ANOVA will be used when comparing application methods. Regression analysis will be 
used to find associations with the speed of being able to complete the application process. Paired t-tests will 
be used to compare questionnaire scores at the final visit to the baseline visit. If the assumptions of these 
tests cannot be met, suitable alternative statistical tests (e.g., Kruskal-Wallis) will be used.  
 
STUDY TIMELINE 
 
  
2020 2020 2020 2021 2021 2021 2021 2021 
  
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
Activity  
IRB Review  
 
  
  
  
  
  
 
 
Data Collection  
 
  
  
  
  
  
 
 
Data Analysis 
 
 
 
 
 
 
 
 
Final Study Report 
 
 
 
 
 
 
 
 
 
PUBLICATION PLANS 
 
An abstract on application methods will be submitted for presentation at Academy 2021 Boston. A summary 
of this work will be submitted as a manuscript to Contact Lens & Anterior Eye.   
 
CONCLUSIONS 
 
This project will be the first to formally evaluate SL application methods in a randomized fashion, work that will 
help guide patient education and doctor prescribing. It may also lead to more patients becoming successful SL 
wearers by streamlining the overall SL fitting process.  
 
REFERENCES 
 
1. 
Harthan J, Nau CB, Barr J, et al. Scleral Lens Prescription and Management Practices: The SCOPE Study. 
Eye Contact Lens 2017. 
2. 
Bergmanson JP, Barnett M, Naroo SA. Scleral gas permeable lenses have come of age. Contact lens & 
anterior eye : the journal of the British Contact Lens Association 2016;39:247-248. 
3. 
Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psychometric properties and validation of the 
Standard Patient Evaluation of Eye Dryness questionnaire. Cornea 2013;32:1204-1210. 
4. 
McAlinden C, Lipson M. Orthokeratology and Contact Lens Quality of Life Questionnaire (OCL-QoL). Eye 
Contact Lens 2017.