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Surgical efficiency and clinical outcome evaluation of Unity VCS combined with 30K cutting speed glass cutting head and 4D phacoemulsification technology for the treatment of macular membrane combined with cataract: a prospective, single arm clinical study

Surgical efficiency and clinical outcome evaluation of Unity VCS combined with 30K cutting speed glass cutting head and 4D phacoemulsification technology for the treatment of macular membrane combined with cataract: a prospective, single arm clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122021
Enrollment
Unknown
Registered
2026-04-08
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract+anterior macular membrane

Interventions

Trial group:All subjects underwent macular membrane removal and vitrectomy using Unity VCS system and 27G 30K cutting head+All subjects underwent cataract phacoemulsification using the Unity VCS syste

Sponsors

Hainan Optometry and Ophthalmology Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age range of 50-75 years old, gender not limited; 2. Diagnosis meets the following conditions (according to the staging criteria of optical coherence tomography proposed by Govetto et al.): (1) Stage 3-4 idiopathic macular membrane, planned to undergo vitreoretinal surgery without the need for intraocular filling; (2) Phase 3: The disappearance of the macular fovea and the appearance of continuous ectopic inner limiting membrane layer (EIFL), but the structure of each layer of the retina is still clear and distinguishable; (3) Stage 4: disappearance of macular fovea, appearance of ectopic inner limiting membrane layer (EIFL), and structural disorder of various layers of the retina; 3. Combining age-related cataracts, evaluated by the attending surgeon to require cataract surgery; 4. No previous history of retinal or vitreous surgery; 5. I have signed the informed consent form and agree to participate in this study and comply with all research procedures and requirements.

Exclusion criteria

Exclusion criteria: 1. Subjects who are found to have retinal tears, retinal detachment, or other retinal lesions during preoperative screening and require vitrectomy with gas or silicone oil intraocular filling; 2. Secondary macular membrane; 3. Combination of glaucoma, high intraocular pressure (>21 mmHg), optic nerve atrophy, high myopia (+3.0 D), posterior staphyloma, or other retinal diseases sensitive to fluctuations in intraocular pressure; 4. History of eye trauma, eye inflammation, previous eye surgery, eye infection, or significant eye lesions such as corneal opacity that may affect surgical procedures; 5.There are serious systemic diseases, including uncontrolled diabetes (glycosylated hemoglobin HbA1c >8.0%).

Design outcomes

Primary

MeasureTime frame
Average total vitrectomy time;

Secondary

MeasureTime frame
Average core vitrectomy time;Average peripheral vitrectomy time;Accumulated dissipated energy (CDE);Energy dissipated within the eye (phacoemulsification energy, unit: J);

Countries

China

Contacts

Public ContactWang Zhaoyang

Hainan Optometry and Ophthalmology Hospital

w494011715@qq.com+86 152 0192 8229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026