The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair
Phase: NA
Conditions: Ptosis, Blepharoptosis
Sponsor: St. Joseph's Healthcare Hamilton

Document Date: October 17, 2017 
 
Project Title: The role of bandage contact lens in post-operative patients undergoing Fasanella 
Servat ptosis repair  
Short Project Title: Bandage contact lens in post operative ptosis patients  
Keywords: Ptosis, blepharoptosis, bandage contact lens, fasanella servat procedure 
 
Collaborators  
Dr. John Harvey, MD 
Dr. Robert Adam, MD 
Dr. Forough Farrokhyar, MPhil, PhD 
Sivisan Suntheralingam, BMSc., MD Candidate 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Document Date: October 17, 2017 
 
 
Project Summary 
Ptosis (eye lid drooping) can be corrected surgically via a procedure called Fasanella 
servat. As eyelid tissue is cut and existing edges sutured back together, the sutures can cause 
some irritation to the eye. Bandage contact lenses are used with the idea that it will protect the 
cornea by providing a protective layer from the sutures (Fontana, 1978). A study conducted by 
Awan et al. suggests that soft contact lenses may be a beneficial choice in surgeries involving the 
upper eyelid (Awan, 2009). To truly see any benefits in patients, studying the effects of bandage 
contact lenses in patients with ptosis surgery is important. Patients who require ptosis surgery on 
both eyes will be part of the study and one eye will be randomized to receive the bandage contact 
lens and the other eye will not. Pain/discomfort and blurred vision will be compared between the 
2 eyes and the results will help us determine if the use of bandage contact lenses is warranted in 
ptosis eye surgery. If the lens is found to be unneeded, this can provide significant healthcare 
cost savings and prevent unnecessary resource utilization. Moreover in terms of the patient 
experience, if the lens is unneeded, this can provide a more comfortable recovery period (no 
hassles with keeping the lens in place) and any unnecessary complications by having a lens on 
the eye (i.e. blurred vision, foreign body sensation, etc.). Bandage contact lenses have been 
demonstrated to have reduced discomfort; however, patients had a preference not to wear them 
during the later parts of their recovery time as they did not experience much in terms of blurred 
vision and discomfort (Ahmed et al, 2001). Moreover, in a study by Shimazi et al. with corneal 
transplantation, it was concluded that no significant benefits were observed through the use of 
bandage contact lenses in their patients (Shimazi et al, 2016). Based on the above, it is 
hypothesized that the bandage contact lenses will not have a major impact on the pain/discomfort 
that the patient experiences and likely will not need to be routinely used.  

Document Date: October 17, 2017 
 
Methods 
Participants: The study population will include patients who have bilateral ptosis (drooping 
eyelids) and will require surgery to correct this, patients in this study will have no other eye 
related pathologies. In general, patients are older than 50 years old and from any demographic.  
Design and Procedure: In this randomized control trial, 30 patients requiring surgery (Fasanella 
Servat procedure) with bilateral ptosis will have one eye randomized to receive a bandage 
contact lens whereas the other eye will not after their surgery. Participants will have a random 
number assigned in order to anonymize data and protect patient identity. We will place a contact 
lens on both eyes and immediately take it off from one (this will be the sham lens eye). 
Randomization of the lens placement will be determined by a flip of a coin (heads – keep lens on 
right eye. Tails – keep lens on left eye). Investigator will randomly generate for each patient 
whether the contact lens will be kept on right or left eye, sham contact lens will be placed on 
other eye, placing it and immediately removing it. Therefore, the patient will not know which 
eye has a lens. Follow up will occur in one week after their surgery where the outcomes will be 
obtained through questionnaires. Upon 1 week follow up, the person administering the 
questionnaire is also blinded as they will not know which eye was randomized to have the lens 
placed.  The primary outcome that will be obtained during the study is the patient’s 
pain/discomfort. This will be obtained using the Eye Sensations Scale where the patient can 
select a box from None, Mild, Moderate, Severe, to Extreme. The secondary outcome that will 
be obtained is to determine if the patient has experienced blurry vision. This will be measured 
using one question from the Ocular Surface Disease Index (OSDI), with a scale from 0 (none of 
the time) to 4 (all of the time).   
 

Document Date: October 17, 2017 
 
Statistics and Analysis 
This randomized controlled trial will enroll consecutive patients and randomizing one eye 
to control treatment and the other eye to the experimental treatment.  Assuming a mean pain 
score of  3.5 with standard deviation of 1.6 for control treatment, we need to enroll 30 patients 
and randomize one eye to control and one to experimental treatment to detect a mean difference 
of one score in pain with beta of 0.1 (90% power) and alpha of 0.05 (significance level of 0.05) if 
the null hypothesis of no difference in population means is true. 
Baseline characteristics will be summarized as frequencies and relative frequencies for 
categorical data and mean and standard deviation for continuous data. Paired t-test will be used 
to compare the pains core between control and experimental eye and mean difference with 95% 
confidence interval will be reported as treatment effect. For categorical outcome measure, 
McNemar test will be used for comparison between control and experimental eye and 
proportions will be reported. A p-value of 0.05 will be set for statistical significance. 
 
Ethics 
Informed consent will be obtained from patients by the staff Ophthalmologists and the 
consent form will be signed by the patient. In terms of any risks to the patient, the intervention 
being studied is currently the standard of care for many clinicians. Thus, participants in this 
study are not being exposed to any additional risk at all as a result of this study. The only risks 
faced by participants are those risks inherent to the surgical procedure that they will consent to 
undergo and these risks are the same for the treatment and control group.  
Timescale 
This project is ready to begin as soon as possible and will be conducted for 6 months.  
 

Document Date: October 17, 2017 
 
References: 
 
1) Fontana FD. Soft lenses to protect the cornea after Fasanella ptosis surgery. (1978). J Am 
Optom Assoc, 49: 316–318. 
 
2) Awan, M. A., Musadiq, M., & Sandramouli, S. (2009). Soft contact lens use for upper 
eyelid surgery. Clin Exp Optom, 92(1), 27-29.  
 
3) Ahmed, I. I., & Breslin, C. W. (2001). Role of the bandage soft contact lens in the 
postoperative laser in situ keratomileusis patient. J Cataract Refract Surg, 27(12), 1932-
1936. 
 
4) Shimazaki, J., Shigeyasu, C., Saijo-Ban, Y., Dogru, M., & Den, S. (2016). Effectiveness 
of bandage contact lens application in corneal epithelialization and pain alleviation 
following corneal transplantation; prospective, randomized clinical trial. BMC 
Ophthalmol, 16(1), 174th ser.