Modified Soft Contact Lens During Vitrectomy

NCT07807436 | Completed

• 1 other identifier: XIANNO1-MSCL-PPV-2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared a modified soft contact lens with balanced salt solution irrigation during pars plana vitrectomy performed with a noncontact wide-angle viewing system. Participants requiring vitrectomy were randomly assigned to have the modified lens placed on the cornea throughout surgery or to receive intermittent balanced salt solution irrigation. The study evaluated whether the modified lens could maintain a clear surgical view and protect the corneal surface. Participants were followed for one month after surgery.

Conditions

Retinal Disease

Keywords

Vitrectomy; Bandage Soft Contact Lens; Corneal Protection; Noncontact Wide-Angle Viewing System

Outcome Measures

Primary Outcomes (1)

• Intraoperative Clarity of the Surgical Field

  Surgical-field clarity was graded on a 4-point ordinal scale: 1, poor visibility requiring corneal epithelial scraping; 2, slightly unclear but permitting basic identification of retinal vessels and the optic disc; 3, clear enough for epiretinal membrane peeling; and 4, excellent visibility permitting delicate macular procedures.

  During pars plana vitrectomy

Secondary Outcomes (8)

• Frequency of Corneal Irrigation

  During pars plana vitrectomy

• Total Operative Time

  During surgery

• Vitrectomy Duration

  During surgery

• Corneal Edema Grade

  Preoperatively and at 1 day, 1 week, and 1 month after surgery

• Corneal Epithelial Fluorescein Staining Score

  Preoperatively and at 1 day, 1 week, and 1 month after surgery

Study Arms (2)

Modified Soft Contact Lens

EXPERIMENTAL

A modified 10.5-mm silicone hydrogel soft contact lens was placed on the corneal surface after surgical draping and maintained throughout pars plana vitrectomy.

Device: Modified Soft Contact Lens

Balanced Salt Solution Irrigation

ACTIVE COMPARATOR

Balanced salt solution was applied intermittently to the corneal surface as required to maintain corneal hydration and clarity during pars plana vitrectomy.

Other: Balanced Salt Solution Irrigation

Interventions

Balanced Salt Solution Irrigation OTHER

Balanced salt solution was applied intermittently to the corneal surface as required during pars plana vitrectomy to maintain corneal hydration and surgical-field clarity.

Balanced Salt Solution Irrigation

Modified Soft Contact Lens DEVICE

A 10.5-mm silicone hydrogel corneal bandage soft contact lens was placed on the corneal surface immediately after surgical draping and maintained throughout pars plana vitrectomy.

Modified Soft Contact Lens

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a retinal disease requiring pars plana vitrectomy.
• Corneal endothelial cell density of at least 2,000 cells/mm².
• No ocular surface disease or significant anterior-segment abnormality.
• No ocular surgery or trauma within the previous month, except intravitreal anti-VEGF injection.
• Considered suitable for ophthalmic surgery under routine clinical conditions.

You may not qualify if:

• Refusal to participate or withdrawal from the study.
• Syncope or inability to tolerate study examinations or surgery.
• Incomplete study data.
• Any condition judged by the investigator to interfere with corneal assessment, including corneal edema secondary to persistently elevated intraocular pressure.

Sponsors & Collaborators

• Northwest University First Hospital (Xi'an No.1 Hospital): lead

Study Sites (1)

Xi'an First Hospital

Xi'an, Shaanxi, 710002, China

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: April 25, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)