Retinal DiseaseNCT07807436
Modified Soft Contact Lens During Vitrectomy
A study testing Modified Soft Contact Lens and Balanced Salt Solution Irrigation in people with Retinal Disease, run by Northwest University First Hospital (Xi'an No.1 Hospital) at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Modified Soft Contact Lens and Balanced Salt Solution Irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Modified Soft Contact Lens Combined With a Noncontact Wide-Angle Viewing System During Vitrectomy
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.
Read the detailed description
This prospective, randomized, parallel-group study enrolled patients with retinal diseases requiring pars plana vitrectomy at Xi'an First Hospital. All operations were performed by the same experienced vitreoretinal surgeon using a standard three-port procedure and the RESIGHT noncontact wide-angle viewing system. In the modified soft contact lens group, a silicone hydrogel corneal bandage lens modified to a diameter of 10.5 mm was placed after surgical draping and maintained throughout the operation. In the comparator group, balanced salt solution was applied intermittently to maintain corneal hydration and clarity.
Intraoperative assessments included total operative time, vitrectomy duration, frequency of corneal irrigation, and graded clarity of the surgical field. Corneal epithelial edema, fluorescein staining, tear film breakup time, and central corneal thickness were assessed before surgery and at 1 day, 1 week, and 1 month after surgery. Ocular surface symptoms were assessed using the Ocular Surface Disease Index before surgery and at 1 month.
- Conditions
- Retinal Disease
- Being tested
- Modified Soft Contact Lens, Balanced Salt Solution Irrigation
- Keywords
- Vitrectomy, Bandage Soft Contact Lens, Corneal Protection, Noncontact Wide-Angle Viewing System
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Soft Contact LensDevice
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.
Balanced Salt Solution IrrigationOther
Balanced salt solution was applied intermittently to the corneal surface as required during pars plana vitrectomy to maintain corneal hydration and surgical-field clarity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Balanced Salt Solution Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During pars plana vitrectomy
Secondary outcomes (8)
Frequency of Corneal Irrigation
Number of balanced salt solution applications used to maintain corneal hydration and clarity during surgery.
Measured: During pars plana vitrectomy
Total Operative Time
Time in minutes from the start to the end of the surgical procedure.
Measured: During surgery
Vitrectomy Duration
Time in minutes from insertion of the first trocar to removal of the last trocar.
Measured: During surgery
Corneal Edema Grade
Corneal edema assessed by slit-lamp microscopy on a 5-point ordinal scale from grade 0 (transparent cornea without edema) to grade 4 (milky edema with obscured intraocular structures).
Measured: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Corneal Epithelial Fluorescein Staining Score
Each corneal quadrant was scored from 0 to 3 after fluorescein staining; quadrant scores were summed to give a total score from 0 to 12, with higher scores indicating greater epithelial injury.
Measured: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Tear Film Breakup Time
Fluorescein tear film breakup time measured in seconds from the last blink to appearance of the first dark spot on the corneal surface.
Measured: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Central Corneal Thickness
Central corneal thickness measured in micrometers using anterior-segment optical coherence tomography.
Measured: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Ocular Surface Disease Index Score
The 12-item Ocular Surface Disease Index was calculated on a 0-to-100 scale, with higher scores indicating more severe ocular surface symptoms.
Measured: Preoperatively and at 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start25 Apr 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest University First Hospital (Xi'an No.1 Hospital)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaogang Yang, Northwest University First Hospital (Xi'an No.1 Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807436
- Sponsor's protocol ID
- XIANNO1-MSCL-PPV-2022
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Modified Soft Contact Lens Combined With a Noncontact Wide-Angle Viewing System During Vitrectomy
- ClinicalTrials.gov ID
- NCT07807436
- Acronym / sponsor ID
- XIANNO1-MSCL-PPV-2022
- Conditions
- Retinal Disease
- Keywords
- Vitrectomy, Bandage Soft Contact Lens, Corneal Protection, Noncontact Wide-Angle Viewing System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northwest University First Hospital (Xi'an No.1 Hospital)University, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, randomized, parallel-group study enrolled patients with retinal diseases requiring pars plana vitrectomy at Xi'an First Hospital. All operations were performed by the same experienced vitreoretinal surgeon using a standard three-port procedure and the RESIGHT noncontact wide-angle viewing system. In the modified soft contact lens group, a silicone hydrogel corneal bandage lens modified to a diameter of 10.5 mm was placed after surgical draping and maintained throughout the operation. In the comparator group, balanced salt solution was applied intermittently to maintain corneal hydration and clarity.
Intraoperative assessments included total operative time, vitrectomy duration, frequency of corneal irrigation, and graded clarity of the surgical field. Corneal epithelial edema, fluorescein staining, tear film breakup time, and central corneal thickness were assessed before surgery and at 1 day, 1 week, and 1 month after surgery. Ocular surface symptoms were assessed using the Ocular Surface Disease Index before surgery and at 1 month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Soft Contact Lens | Experimental | Device: Modified Soft Contact LensA modified 10.5-mm silicone hydrogel soft contact lens was placed on the corneal surface after surgical draping and maintained throughout pars plana vitrectomy. |
| Balanced Salt Solution Irrigation | Active comparator | Other: Balanced Salt Solution IrrigationBalanced salt solution was applied intermittently to the corneal surface as required to maintain corneal hydration and clarity during pars plana vitrectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Soft Contact LensA 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. | Device | Modified Soft Contact Lens |
| Balanced Salt Solution IrrigationBalanced salt solution was applied intermittently to the corneal surface as required during pars plana vitrectomy to maintain corneal hydration and surgical-field clarity. | Other | Balanced Salt Solution Irrigation |
Primary outcome
Intraoperative Clarity of the Surgical Field
Time frame: During pars plana vitrectomy
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.
8 secondary outcomes
Frequency of Corneal Irrigation
Time frame: During pars plana vitrectomy
Total Operative Time
Time frame: During surgery
Vitrectomy Duration
Time frame: During surgery
Corneal Edema Grade
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Corneal Epithelial Fluorescein Staining Score
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Tear Film Breakup Time
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Central Corneal Thickness
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Ocular Surface Disease Index Score
Time frame: Preoperatively and at 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Retinal Disease
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingPhase 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
RecruitingObservational study
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
Age-Related Macular Degeneration
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Soft Contact Lens and Balanced Salt Solution Irrigation in people with Retinal Disease, run by Northwest University First Hospital (Xi'an No.1 Hospital) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Clarity of the Surgical Field (time frame: During pars plana vitrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.