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Completed

NCT Number: NCT05242653

Comparison of Wound Integrity for Clear Corneal Cataract Incisions

This is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

About this study

Compared with other incision types , clear corneal incision has the advantages of simple operation, small incision and good healing. It has been widely used in recent decades and has become the most commonly used incision type in phacoemulsification cataract surgery.However, there is no unified standard for the closed method of the clear corneal incision, and some studies have shown that the wound Integrity of clear corneal incision is not well.In the poorly closed incision, the risk of infection increased due to the leakage .Especially in 2.2mm incision, the frequent entry and exit of the instrument reduces the corneal rebound ability at the incision so that the incision is hard to closed. Ensuring wound Integrity for clear corneal cataract incision is the key to the success of cataract surgery.

Clinically closed methods include stromal hydration and suture.The effectiveness of stromal hydration as one of the most commonly used methods has been validated, but also adds additional negative effects. Additionally, the suture extends the operation time and improves the operation cost, and is also accompanied by some complications, which has been less used. Exploring a safe and effective closed method will benefit for most cataract patients.

This study intends to evaluate the safety and efficacy of a closed method that incision is pressed by a cotton swab.The investigators planned to select 130 cataract patients who met the inclusion criteria. The investigators will press the clear corneal incision with a cotton swab in experimental group, while the control group used stromal hydration to close the corneal incision. Wound Integrity, wound leakage, corneal thickness at the incision, keratometric value at the incision, anterior chamber depth and incidence of incision-related descemet membrane detachment were compared between the two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 years old;
  • Nuclear grade is III or IV;
  • Visually significant cataract;
  • The patient is willing and able to complete all necessary follow-ups and examinations.

Exclusion criteria

  • Intraoperative or postoperative complications: such as intraoperative posterior capsule rupture, the rupture of zonule, secondary glaucoma, endophthalmitis, etc.;
  • Combined with other eye diseases: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
  • History of intraocular surgery;
  • Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
  • Any condition that the study physician considers to be an impediment to the clinical trial.

Treatment and study plan

pressure by a cotton swab

Procedure

All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with pressure by a cotton swab.

stromal hydration with the balanced salt solution(BSS)

Procedure

All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with stromal hydration.

Primary outcomes

  1. Degree of incision closure

    Time frame: During surgery

    Degree of incision closure is evaluated by intraoperative optical coherence tomography.

Secondary outcomes

  1. Rate of wound leakage

    Time frame: During surgery

    Rate of wound leakage is evaluated by fluorescein sodium.

  2. Corneal thickness

    Time frame: 1 hour after surgery and 1 day after surgery

    Corneal thickness is measured by Casia 2.

  3. Corneal curvature

    Time frame: 1 hour after surgery and 1 day after surgery

    Corneal curvature is measured by Casia 2.

  4. Anterior chamber depth

    Time frame: 1 hour after surgery and 1 day after surgery

    Anterior chamber depth is measured by Casia 2.

  5. Rate of incision-related descemet membrane detachment during surgery

    Time frame: During surgery

    Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.

  6. Rate of incision-related descemet membrane detachment after surgery

    Time frame: 1 hour after surgery and 1 day after surgery

    Rate of incision-related descemet membrane detachment after surgery is evaluated by Casia 2.

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Comparison of Wound Integrity for Clear Corneal Cataract Incisions: Pressure Versus Stromal Hydration

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2022
Registry last updated
Sep 10, 2022

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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