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The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

NCT ID: NCT04447157

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2020-06-20

Brief Summary

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By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.

Detailed Description

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Conditions

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Microspherophakia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Microspherophakia

This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Microspherophakia was diagnosed and lens diameter\<9mm;
* The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
* Lens dislocated into the anterior chamber;
* Lens dislocation caused elevated intraocular pressure (IOP);
* The lens contacted the corneal endothelium;
* Cataract;
* Corneal endothelial cell density\>1000/mm2;
* The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；
* There was possible improvement in postoperative visual acuity measured by retinometer.

Exclusion Criteria

* The lens is centered and the position of the lens is stable;
* Glasses can correct the vision obviously;
* The reason for the elevated IOP was independent with the lens;
* A high possibility of corneal decompensation after surgery;
* Fundus function was poor and it is not expected to improve the vision after surgery;
* Combined with other ocular diseases which were not suitable for IOL implantation;
* Combined with a systemic disease that the patient cannot tolerate the surgery.
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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xuwen2020-465

Identifier Type: -

Identifier Source: org_study_id