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NCT Number: NCT06617273

Cataract Surgery with Near Normal Eye Pressure in Patients with Diabetic Retinopathy

Diabetes mellitus is a chronic metabolic disease that can lead to visual impairment and eye complications such as diabetic retinopathy and diabetic macular edema. Diabetics are considered a vulnerable patient group for cataract surgery, as microincision phacoemulsification (MICS) in diabetics is associated with a higher risk of postoperative swelling of the macula and cornea (macular or corneal edema). In addition, the ultrasound energy emitted during MICS, high and fluctuating intraocular pressure and the movement of surgical instruments and lens material are the main causes of surgical trauma. The medical device "Centurion Vision System" with the "Active Sentry" handpiece was developed specifically to improve the stability of the anterior chamber during surgery and to enable operations at low, almost normal physiological intraocular pressure settings.

The central question of the study is therefore, whether a stable intraocular pressure close to physiological normal conditions (28 mmHg) during surgery can lead to a reduction in surgical trauma. In this prospective and randomized study, patients suffering from diabetes and having a planned bilateral MICS are included in one of two study arms:

A) The participant is operated on with an IOP of 28 mm Hg in the better eye and an IOP of 50 mm Hg in the worse eye or B) the participant is operated on with an IOP of 28 mm Hg in the worse eye and an IOP of 50 mm Hg in the better eye.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Cataract Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Lens Diseases Retinal Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck, University Hospital for Ophthalmology and Optometry

Innsbruck, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for immediate sequential bilateral microincision cataract surgery
  • Diagnosis of Diabetes Mellitus treated with oral medication or insulin therapy and confirmed by HbA1c ≥6,5 %
  • Presence of diabetic retinopathy grade ≥1 on the international clinical diabetic retinopathy (ICDR) severity scale
  • LOCS 2-4 with no more than 1 grade difference between both eyes
  • Male or female patient aged 50 - 85 years of age at time of consent
  • Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature

Exclusion criteria

  • Participation in another clinical trial within 30 days before pre-screening and throughout the trial
  • Prior intraocular surgery of any type
  • History of diabetic macular edema
  • Presence of macular edema, defined as central retinal thickness of >300 µm plus intraretinal or subretinal fluid on OCT within range of 1mm of foveal center
  • Presence of any retinal or choroidal disease, other than diabetes, that could affect retinal thickness
  • Known history of uveitis
  • Documented use of systemic or topical steroid or other immunosuppressive medication within the last 3 months
  • ACF >10 ph/ms. ACF difference between right and left eye > 4ph/ms
  • Difference of DRP grading between right and left eye of more than 1 grade (ICDR)
  • Inability to measure total macular volume due to, but not limed to, too dense cataract, vitreous bleeding
  • Woman of childbearing potential (WOCBP) who is breastfeeding, has a positive urine pregnancy test, is not willing to undergo a urine pregnancy test upon entering or exiting the study, intends to become pregnant during the study, or does not agree to use adequate birth control methods for the duration of the study
  • Patients in possession of an active implantable medical device (AIMD)

Treatment and study plan

Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation

Device

Cataract surgery in patients with diabetic retinopathy using active anterior chamber pressure sensing and regulation

Primary outcomes

  1. Delta ACF

    Time frame: 1 week

    Difference from pre- to postoperative ACF (delta ACF) at day 1 (FU1) and day 7 (FU2) after cataract surgery.

Secondary outcomes

  1. BCVA

    Time frame: 1 month

    Difference between pre- to postoperative BCVA

  2. 5mm corneal volume

    Time frame: 1 month

    Pentacam derived

  3. Anterior chamber depth

    Time frame: 1 month

    Pentacam derived

  4. Mydriatic pupil width

    Time frame: 1 month

    Pentacam derived

  5. Endothelial cell density

    Time frame: 1 month

    Quantifying assessment of endothelial cell loss via specular microscopy; (28 +-3) days after surgery.

  6. Assessment of intraoperative complications

    Time frame: 1 month

    Screening for the presence of posterior capsular ruptures

  7. Assessment of postoperative complications

    Time frame: 1 month

    Presence of cystoid macular edema

  8. Intraoperative events

    Time frame: Day 0 (Surgery)

    Assessment of any event in regard to phacoemulsification settings

  9. Central macular thickness

    Time frame: 1 month

    Pre- and postoperative assessment of central macular thickness via optical coherence tomography (OCT)

  10. Total macular volume

    Time frame: 1 month

    Pre- and postoperative assessment of total macular volume via optical coherence tomography (OCT)

  11. Retinal Nerver fiber layer thickness (RNFL)

    Time frame: 1 month

    Pre- and postoperative assessment of RNFL via optical coherence tomography (OCT)

  12. Central corneal thickness

    Time frame: 1 month

    Pre- and postoperative assessment of central corneal thickness via optical coherence tomography (OCT)

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Near Normal Intraocular Pressure Cataract Surgery in Patients with Diabetic Retinopathy Using Active Anterior Chamber Pressure Sensing and Regulation - a Randomized Controlled Comparative Clinical Trial

Acronym: NNIOP-PHACO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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