Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Conditions

• Vitreomacular Traction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pneumatic Vitreolysis (C3F8 injection) — DEVICE
  Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.
• Observation — OTHER
  No intervention; sham injection only

Study Details

Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.

Key Dates

First listed

Aug 27, 2018

Start date

Oct 16, 2018

Status verified

Sep 2022

Primary completion

Aug 6, 2020

Completion

Aug 6, 2020

Study Design

Enrollment

46 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pneumatic Vitreolysis
  Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.
• Placebo Comparator: Observation
  Participants randomized to the observation group will receive a sham injection.

Primary Outcome Measure

Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy [ Time Frame: at 24 Weeks ]

Locations (41)

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