Clinical trial NCT05828251: Full Thickness Macular Hole; Should it be Handled Subacutely?
Official title: Full Thickness Macular Hole; Should it be Handled Subacutely?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Full Thickness Macular Hole
Keywords: Phako
Vitrectomy
Phako-vitrectomy
FTMH
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial in the first part om of the study, 28 patients in each arm.

Prospective study in second part of the study with 28 patients.
Primary purpose: TREATMENT

Brief summary: Full thickness macular hole, FTMH, is a retinal disease involving the fovea that cause central vision loss, metamorphopsia and central scotoma. The most effective treatment for FTMH is a pars plana vitrectomy and a tamponade with expansile gas. It is well known that vitrectomy accelerates cataract development. Vitrectomy can therefore be combined with cataract surgery in the same setting, a procedure that is shown to be safe, although increased inflammation and rates of central macular edema have been reported in some studies. Cataract surgery can also be performed prior or deferred until compromising the visual acuity after vitrectomy. Cataract-surgeries are more challenging in vitrectomized eyes due to lack of vitreous support and risk of loose zonules. The normal practice for FTMH at our department is therefore cataract surgery followed by vitrectomy 4 weeks later. A combined phaco-vitrectomy procedure is offered to patients who are at the labor market or when general anesthesia is required for the surgery. In non-presbyopic patients (\<50 years) only vitrectomy is performed.

The visual improvement after surgery seems to be dependent on preoperative characteristics, such as the preoperative visual acuity, size of the hole and the duration of symptoms. The duration of symptoms is a known prognostic factor, and recently shown that the longer duration, the worse visual outcome. The precise timeframe for the optimal final outcome is not known.

The combined surgery is known to be safe in the treatment for epiretinal membrane, where a intravitreal gasfill is not necessary. However, the use of gas in FTHM surgery causes risk of increased movement of the newly inserted intraocular lens. This can lead to increased anterior segment inflammation with ensuing vision threatening cystic macular edema, as mentioned above.

The purpose of this study is to investigate whether small FTMH with a short duration of symptoms have better visual outcome with a prompt combined phako-vitrectomy (within two weeks), compared to the current standard of care of receiving cataract surgery as soon as possible and vitrectomy 4 weeks later. How the delay of surgery affects the visual outcome will also be investigated, by including patients with longer duration of symptoms. The main hypothesis is that the chance of better visual outcome is higher for macular holes with early surgery compared to the current standard of care and that the duration of symptoms has significant impact on the visual outcome.

Method

The study consists of 2 parts.

1. Patients with idiopathic FTMH \<400µm in diameter (as defined by The international vitreomacular traction study group classification), with a duration of symptoms of less than 30 days will be randomized into 2 groups:

   Group1: Combined phaco-vitrectomy within 2 weeks (after referral). Group 2: Current standard of care with cataract surgery as soon as possible and vitrectomy 4 weeks later.
2. Group 3: Patients with small holes \<400µm, with a duration of symptoms of more than 3 months and less than one year will be included in this part of the study. These patients will be treated and followed as in Group 2.

They will be reviewed a total of 7 times in Group 1 and 9 times in Group 2 and 3: a preoperative examination followed by 6/8 postoperative examinations. Additional examinations will be scheduled if needed.


Eligibility criteria: Inclusion Criteria:

* Idiopathic full thickness macular hole
* Duration of symptoms of \<30 days for Group 1 and 2
* Duration of symptoms of 3-12 months for Group 3
* FTMH size \<400µm
* \>18 years
* Able to give informed consent
* Compliance for postoperative positioning

Exclusion Criteria:

* High myopia (≤-3)
* Traumatic macular hole
* Prior ocular surgery, including cataract surgery
* Other ocular diseases compromising the visual acuity (i.e., AMD, diabetic retinopathy, previous vein occlusion)
* Posterior vitreous detachment (Weiss ring)

Primary outcomes:
measure: Visual acuity
timeFrame: 12 months after vitrectomy
Secondary outcomes:
measure: Metamorphopsia
timeFrame: 12 months after vitrectomy
measure: Hole closure rates
timeFrame: Measured 4 weeks after surgery
measure: Microperimetry
timeFrame: 12 months after surgery
measure: Anterior chamber inflammation
timeFrame: 1 day and 1 week after the first surgery
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet, Denmark
state: Copenhagen
Study officials:
affiliation: Rigshospitalet, Denmark
name: Morten Dornonville de la Cour, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: