Duration of Face Down Positioning for Full-Thickness Macular Hole Repair

Macular Holes Clinical Trial

Official title:

Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: A Randomized Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000111
• Other study ID #: 16100
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: St. Joseph's Healthcare Hamilton
• Contact: Varun Chaudhary, MD, FRCSC
• Phone: 905-573-7777
• Email: vchaudh[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients with an idiopathic full-thickness macular hole
• Symptom duration of less than 6 months
• Patient must agree to participate in this investigation

Exclusion Criteria:

• Macular hole minimum diameter >1000 µm
• A history of high myopia (> -6)
• Traumatic macular hole
• Amblyopia
• Retinal vein occlusion
• Inflammatory eye diseases
• Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Behavioral:
• 3 Days of face-down positioning
Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
• 7 Days of face-down positioning
Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital King Campus	Stoney Creek	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.	The recruitment rate will be calculated during the recruitment period.
Primary	Retention Rate	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.	The retention rate will be calculated at 3-months post-operatively.
Primary	Completion Rate	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.	The completion rate will be calculated at 3-months post-operatively.
Primary	Recruitment Time	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.	The recruitment time will be calculated during the recruitment period.
Secondary	Macular Hole Closure Rate	The rate of macular hole closure will be evaluated by 2-independent readers masked to treatment allocation. They will grade the outcome as open or closed. Outcomes classified as open will be further divided into open and flat (without a cuff of subretinal fluid) or open and elevated (with a cuff of subretinal fluid).	3-months post-operatively
Secondary	Best-Corrected Visual Acuity (BCVA)	Patient best-corrected visual acuity will be measured by Snellen visual acuity. With this measure of visual acuity, visual acuity can range from 20/10 (best) to 20/1000 (worst). If the patient is unable to read the chart at any distance, patients will next be assessed whether they can count figures at a given distance, if not, they will be tested to see whether they can perceive hand motion and if not, if they can perceive any light.	3-months post-operatively
Secondary	Vision specific quality of life measure	The National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be administered to patients. Possible patient scores range from 0 to 100 with a higher score representing higher vision-related quality of life.	3-months post-operatively
Secondary	Compliance with Face Down Positioning	Compliance will be assessed with self-administered questionnaires assessing the patients' compliance during the morning, midday, evening, and overnight. The possible range of scores is from 1 to 10 with higher scores indicating better compliance.	While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.
Secondary	Complication Rates	Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage	Rates will be determined for the entire follow-up period (3-months)
Secondary	Health Related Quality of Life Measure	The Quality of Life Scale (QOLS) will be administered to patients. The range of possible patient scores is from 16 to 112. Higher scores indicate higher quality of life.	3-months post-operatively