Comparison of Wound Integrity for Clear Corneal Cataract Incisions

NCT05242653 | Completed

• 1 other identifier: 2021KYPJ208
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Degree of incision closure

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

  During surgery

Secondary Outcomes (6)

• Rate of wound leakage

  During surgery

• Corneal thickness

  1 hour after surgery and 1 day after surgery

• Corneal curvature

  1 hour after surgery and 1 day after surgery

• Anterior chamber depth

  1 hour after surgery and 1 day after surgery

• Rate of incision-related descemet membrane detachment during surgery

  During surgery

Study Arms (2)

cotton swab

EXPERIMENTAL

Procedure: pressure by a cotton swab

balanced salt solution (BSS)

ACTIVE COMPARATOR

Procedure: stromal hydration with the balanced salt solution（BSS）

Interventions

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.

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.

balanced salt solution (BSS)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Liu Z, Lin H, Jin L, Qu B, Liu J, Zheng Y, He M, Luo L, Liu Y. Swab Pressing vs Stromal Hydration to Prevent Incision Leakage and Transient Collapse of Anterior Chamber in Phacoemulsification: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jun 1;141(6):574-581. doi: 10.1001/jamaophthalmol.2023.1491.

  PMID: 37166786 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 16, 2022
• Study Start: February 17, 2022
• Primary Completion: June 30, 2022
• Study Completion: September 8, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

CN (1)