ILM Peeling Versus Inverted Flap Technique for Treatment of Macular Hole: Near Visual Acuity Outcomes
Internal Limiting Membrane Peeling Versus Inverted Flap Technique for Treatment of Idiopathic Full-thickness Macular Hole: a Comparative Study of Near Visual Acuity Outcomes Using Salzburg Reading Desk.
1 other identifier
interventional
60
1 country
1
Brief Summary
A prospective randomised study comparing the near visual acuity outcomes using Salzburg Reading Desk in pseudophakic patients with idiopathic full-thickness macular hole treated with pars plana vitrectomy with internal limiting membrane peeling versus inverted flap technique. The aim of the study is confirm or disprove the hypothesis, that the near visual acuity results of pars plana vitrectomy with inverted flap technique for idiopathic macular hole are not inferior to pars plana vitrectomy with complete internal limiting membrane peeling technique. Patients will be followed for 6 months after the operation and near best corrected visual acuity testing on Salzburg reading desk, distance best corrected visual acuity on ETDRS tables and microperimetry will be performed and compared between both groups. Also the macular hole closure rate and complication rate will be compared between both groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2021
CompletedStudy Start
First participant enrolled
January 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 9, 2022
August 1, 2022
2.4 years
January 2, 2021
August 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Near best corrected visual acuity on Salzburg reading desk
Near best corrected visual acuity defined as the smallest text size where reading speed is over 80 wpm or word miss rate is 1 or lower as per Salzburg reading desk exam.
Month 6
Microperimetry - macular integrity
Change from baseline macular integrity score from MAIA Confocal Microperimeter Expert exam 4-2 of the study eye at month 6.
Baseline and month 6
Microperimetry - avarage threshold
Change from baseline avarage threshold score from MAIA Confocal Microperimeter Expert exam 4-2 of the study eye.exam 4-2 of the study eye at month 6.
Baseline and month 6
Microperimetry - fixation stability
Change from baseline fixation stability P1 and P2 from MAIA Confocal Microperimeter Expert exam 4-2 of the study eye at month 6.
Baseline and month 6
Macular hole closure rate
Macular hole closure rate defined as a flattened and reattached hole rim along the whole circumference of macular hole on the OCT examination of the macular region of the study eye.
Month 6
Secondary Outcomes (3)
Distance best corrected visual acuity
Baseline and month 6
Occurrence of perioperative complications
Month 3
Occurrence of postoperative complications
Month 6
Study Arms (2)
ILM peel
ACTIVE COMPARATORPatients who will undergo 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling and SF6 tamponade.
Inverted flap
EXPERIMENTALPatients who will undergo 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade.
Interventions
Standard 3 port 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling around the macular hole after brilliant blue dye staining and sulfur hexafluoride (SF6) tamponade
Standard 3 port 25-gauge pars plana vitrectomy with inverted flap technique after brilliant blue dye staining and SF6 tamponade. "Flower petal" type of inverted flap will be performed - multiple small ILM flaps will be created around the macular hole and placed over the macular hole.
Eligibility Criteria
You may qualify if:
- Adult patients over 18 years of age
- With idiopathic full thickness macular hole verified on OCT (Gass stage 2-4)
- Minimal macular hole size under 1000 um
- Pseudophakic
You may not qualify if:
- Presence of other ocular pathology influencing visual acuity (e.g. age-related macular degeneration, diabetic retinopathy etc.)
- Unwilling to sign the informed consent form
- Unable to come to the study visits
- Health status not allowing participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Faculty hospital Kralovske Vinohrady
Prague, 100 34, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Pencak, M.D.
Faculty Hospital Kralovske Vinohrady
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 2, 2021
First Posted
January 6, 2021
Study Start
January 5, 2021
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
August 9, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share