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

Completed

• Conditions: Microspherophakia

• Registration Number: NCT04447157
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-07-01
• Status Verified: 2020-06
• Primary Completion: 2020-06-10
• Study Completion: 2020-06-20
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Last Update Submitted: 2020-06-28
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anterior chamber depth	6 month postoperation	Anterior chamber depth measured using Ultrasound biomicroscope
Intraocular pressure	6 month postoperation	intraocular pressure measured using non-contact tonometer
PCIOL tilt degree	6 month postoperation	PCIOL tilt degree measured using Ultrasound biomicroscope
PCIOL decentration distance	6 month postoperation	PCIOL decentration distance measured using Ultrasound biomicroscope
Visual function	6 month postoperation	uncorrected distance visual acuity (UDVA) measured using a decimal chart
Endothelial cell density	6 month postoperation	Endothelial cell density was measured by specular microscopy