Full Thickness Macular Hole; Should it be Handled Subacutely?

NCT ID: NCT05828251

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2028-04-01

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.

Conditions

Full Thickness Macular Hole

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined Phako-Vitrectomy for FTMH

Study 1: Patient randomized to this arm will receive a combined phako-vitrectomy within two weeks from referall day.

Group Type: EXPERIMENTAL

Combined phako-vitrectomy

Intervention Type: PROCEDURE

Phakoemulsication and pars plana vitrectomy are performed in the same setting. This procedure is normally only offeres to selected cases at our department.

Sequential phako and vitrectomy for FTMH

Study 1: Patients randomized to this arm will receive a standard phacoemulsification as soon as possible. About four weeks after phacoemulsification a vitrectomy is performed.

Group Type: ACTIVE_COMPARATOR

Vitrectomy (Sequential phakoemulsification and vitrectomy)

Intervention Type: PROCEDURE

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Phako (Sequential phakoemulsification and vitrectomy)

Intervention Type: PROCEDURE

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Longstanding FTMH

Study 2: Patients with symptomduration of 3-12 months will be included in this part of the study in a prospective design.

Group Type: OTHER

Vitrectomy (Sequential phakoemulsification and vitrectomy)

Intervention Type: PROCEDURE

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Phako (Sequential phakoemulsification and vitrectomy)

Intervention Type: PROCEDURE

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Interventions

Vitrectomy (Sequential phakoemulsification and vitrectomy)

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Intervention Type: PROCEDURE

Combined phako-vitrectomy

Phakoemulsication and pars plana vitrectomy are performed in the same setting. This procedure is normally only offeres to selected cases at our department.

Intervention Type: PROCEDURE

Phako (Sequential phakoemulsification and vitrectomy)

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Asrin Rasul

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Dornonville de la Cour, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet, Denmark

Glostrup Municipality, Copenhagen, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Asrin Rasul, MD

Role: CONTACT

asrin.rasul@regionh.dk

004522365420

Ulrik Christensen

Role: CONTACT

ulrik.correll.christensen@regionh.dk

004540261670

Facility Contacts

Morten Dornonville de la Cour, MD, Prof.

Role: primary

Other Identifiers

Rigshospitalet-RS studie

Identifier Type: -

Identifier Source: org_study_id